Atherosclerosis of ArteryNCT05214872
The Impact of Selected Factors on the Cardiovascular System in Chronic Kidney Disease
An observational study of Atherosclerosis of Artery and Inflammation, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Chronic kidney disease (CKD), is characterized by accelerated development of atherosclerosis and advanced remodelling of vessels and the heart. It is associated with many factors, including inflammation, arterial hypertension, hyperlipidemia, hyperhomocysteinemia, secondary hyperparathyroidism, and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis of Artery, Inflammation, Chronic Kidney Diseases
- What is being tested?
- laboratory parameters - complete blood count, body mass index (BMI) [kg/m^2] calculation and selected parameters of oxidative stress (1)
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 1 sitePoland
- Study dates
- 25 Mar 2016to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 252 people have been enrolled on the study, including 106 consecutive dialyzed patients (HD group), treated in 2016-2018 at the Nephrology Outpatient Clinic and the Clinical Hospital's Dialysis Center. H. Święcickiego in Poznań; 37 32 healthy participants (control group), serving as a comparative group.
Criteria:
The following criteria of qualifying for the study were adopted for all respondents:
- 18 years of age or older,
- written consent to participate in the study,
- no active inflammatory process,
- no neoplastic disease or a neoplastic disease whose treatment was stopped at least 10 years ago,
- no history of immunosuppressive treatment,
- stable liver function (not more than two times increased activity of transaminases), HBs antigen and anti-HCV negative antibodies,anti-HIV negative antibodies.
In addition, for CKD patients (CKD1-2) and PREDIALYSIS GROUP, the following additional inclusion conditions were applied:
- no acute cardiovascular complications, ie acute heart failure, hypertensive crisis, acute coronary syndrome, at the time of study entry.
At the same time, depending on the technique of renal replacement therapy used, additional inclusion criteria were established for each of the subgroups:
in group HD:
- a minimum of 6 months of treatment with repeated hemodialysis, 3 times a week, for a minimum of 10 hours a week,
- arteriovenous fistula as a vascular access for hemodialysis,
- Estimated dialysis adequacy ratio (eKt / V) of at least 1.2. in the PD group:
- treatment duration UP to a minimum of 6 months, Kt / V ≥1.8 l / week / 1.73 m2.
For CARD patients, additional conditions include:
- no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,
- history of angina pectoris,
- documented history of at least one acute coronary syndrome,
- admission to the Department of Intensive Care of Cardiology and Internal Diseases in order to perform a planned coronary angiography, on the day of admission to the study without signs of the acute coronary syndrome, no additional comorbidities, ie those that do not result directly or indirectly from coronary heart disease.
In turn, for the HV group (control group), additional conditions include:
- no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,
- no obvious signs of cardiovascular impairment in the history and at the time of study entry, estimated on the basis of normal blood pressure (<140/90 mmHg), no abnormalities in the medical history and physical examination,
- not taking any medications on a regular basis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of Selected Factors on the Cardiovascular System in Patients With Different Chronic Kidney Disease Stages
Chronic kidney disease (CKD), is characterized by accelerated development of atherosclerosis and advanced remodelling of vessels and the heart. It is associated with many factors, including inflammation, arterial hypertension, hyperlipidemia, hyperhomocysteinemia, secondary hyperparathyroidism, and oxidative stress. Hypertension is one of the most critical risk factors for cardiovascular complications. It leads to the formation of structural changes in the vascular system: it impairs the activity of the endothelium, causes hypertrophy and remodelling of the vascular wall, reduces the susceptibility of the vessels and accelerates the development of atherosclerosis. This study aimed to identify the processes and their representative markers, the concentration of which in the serum may reflect the cardiovascular system status and can predict the increased mortality in HD patients.
Read the detailed description
Chronic Kidney Disease has a significant impact on the cardiovascular system. From many different complications of CKD, one to mention is arterial stiffness. This disorder results from many pathologies, including inflammation, arterial hypertension, carbohydrate metabolic disorders, lipid disorders, vascular calcification, chronic inflammation, and oxidative stress.
The main goal of this study was to analyze the mechanisms leading to the increased tendency to cardiovascular disturbances in CKD, with particular focus on the parameters of oxidative stress, inflammation and the results of imaging examinations (intima-media thickness (IMT) assessments) and other non-invasive cardiological examinations based on the results using the Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom) The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer.
Besides, studied participants were followed 2 years after enrollment to study for recording cardiovascular-related death.
- Conditions
- Atherosclerosis of Artery, Inflammation, Chronic Kidney Diseases, Dialysis; Complications, Cardiovascular Diseases
- Being tested
- laboratory parameters - complete blood count, body mass index (BMI) [kg/m^2] calculation, selected parameters of oxidative stress (1), metalloproteinases, parameters of lipids metabolism in the serum
- Keywords
- risk factors, chronic kidney disease, inflammation, oxidative stress, atherosclerosis, mortality
- Medical subject headings
- Inflammation, Renal Insufficiency, Chronic, Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory parameters - complete blood countDiagnostic test
the complete blood count was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA):
- hemoglobin (HGB) [g/dl];
- red blood count (RBC) [10^12/l];
- hematocrit (HCT) [l/l];
- white blood cells (WBC) [10^9/l];
- platelet count (PLT) [10^9/l]
body mass index (BMI) [kg/m^2] calculationOther
body mass index (BMI) [kg/m^2] was calculated by dividing a person's weight (post-HD weight in HD group) [kg] by the squared their body height [m]
selected parameters of oxidative stress (1)Diagnostic test
Serum concentration of:
- advanced glycation ends products (AGE) [µg/mg protein];
- 3-nitrotyrosine (3-NT) [µmol/mg protein];
- advanced oxidation protein products (AOPP) [µmol/mg protein];
- carboxymethyle(lysine) (CML) [µg/mg protein] were determined with the enzyme immunoassay methods (ELISA) using Shanghai Sunred Biological Technology Co kits, China.
metalloproteinasesDiagnostic test
metalloproteinases in the serum [ng/ml]:
- metalloproteinase 9 (MMP-9) in the serum was determined by the ELISA method using the Quantikine Human MMP-9 (total) kit, by R\&D Systems, Canada;
- tissue inhibitor of metalloproteinase 1 (TIMP-1) in the serum - was determined by the ELISA method using the Quantikine Human TIMP-1 kit, manufactured by R\&D Systems, Canada;
- the MMP-9/TIMP-1 ratio was calculated by the quotient of the MMP-9 and the TIMP-1 concentration.
parameters of lipids metabolism in the serumDiagnostic test
- total cholesterol (T-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA;
- low-density lipoprotein cholesterol (LDL-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA;
- high-density lipoprotein cholesterol (HDL-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA;
- triglycerides (TG) [mg/dl] - were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA;
- the concentration of low-density lipoprotein (LDL-C) cholesterol - was determined from Friedewalds' equation (LDL-C [mg/dl] = total cholesterol (T-C) [mg/dl]- HDL-C [mg/dl]- TG[mg/dl]/5).
parameters of iron metabolismDiagnostic test
- iron concentration [mg/dl] - was analyzed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA;
- total iron-binding capacity (TIBC) [mg/dl] - was analyzed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA;
- the unsaturated iron-binding capacity (UIBC) [mg/dl] was determined by an equation in which iron concentration in plasma is subtracted from TIBC [mg/dl];
- ferritin [ng/ml] concentration was determined with the Modular E-170 biochemical analyzer from Roche Diagnostics, USA.
selected inflammatory markersDiagnostic test
- high-sensitivity C-reactive protein (hsCRP) [mg/l] was measured using DADE Behring, USA and the DADE nephelometer Behring Analyzer II;
- neopterin [nmol/l] was determined by using the Neopterin ELISA kit, DRG International, Inc., USA;
- interleukin 18 (IL-18) [pg/ml] concentration was determined by Colorimetric Sandwich ELISA, Quantikine Human IL-18 R\&D Inc., USA.
carotid intima-media thickness (IMT)Device
carotid intima-media thickness (IMT) [mm] was measured by The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer.
Two longitudinal projections were assessed (anterolateral and posterolateral). The distal 1 cm of the common carotid artery just proximal to the bulb was measured by means of a computer analysis system (Medical Imaging Applications, LLC).
non-invasive cardiological examinationsDevice
For non-invasive cardiological examinations, the Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) were used.
Main assessed variables: heart rate (HR) [beats per minute [bpm]]; ejection duration (ED) [millisecons]; peripheral systolic (pSBP) and diastolic blood pressure (pDBP) [mm Hg]; peripheral mean arterial pressure (pMAP) [mm Hg]; peripheral end-systolic pressure (pESP) [mm Hg]; central systolic (cSBP) and diastolic blood pressure (cDBP) [mm Hg]; central mean arterial pressure (cMAP) [mm Hg]; central augmented pressure (cAP) [mmHg]; central mean pressure of diastole (cMPD)[mm Hg]; central mean pressure of systole (cMPS) [mm Hg]; central end-systolic pressure (cESP) [mm Hg].
vessel stiffness assessmentDevice
The following parameters of vessel stiffness were assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom):
- reflection index (RI) [in percentages [%]];
- vascular stiffness index (SI) [m/s];
- peripheral pulse pressure (pPP) [mm Hg];
- central puls pressure (cPP) [mm Hg]
- peripheral pulse pressure/central pulse pressure (pPP/cPP ratio).
cardiovascular (CV)-related death recording during 2-year follow-upOther
During a 2-year follow-up from the enrollment to this study, CV-related fatal incidents history has been recorded for each subject separately. The primary endpoint was fatal acute myocardial infarction (AMI) or acute ischemic stroke or any unexpected or sudden death only if autopsy proved CV-related. If there was doubt about the cause of death or there was no contact with the patient during the two years from study enrollment, that patient was excluded and not considered further.
glucose (Glu)Diagnostic test
glucose (Glu) [mg/dl] was assessed in the serum by a routine technique using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
klothoDiagnostic test
klotho [ng/ml] - was analyzed in the serum by Human KL(Klotho) [ng/ml] ELISA Kit, Shanghai Sunred Biological Technology Co kit, China.
fibroblast growth factor 23 (FGF-23)Diagnostic test
FGF-23 [pg/ml] - was analyzed in rhe serum using Human FGF-23 ELISA Kit, Sigma-Aldrich, USA.
parameters of calcium and phosphate metabolismDiagnostic test
- total and ionized calcium [mg/dl],
- phosphate [mg/dl],
- intact parathormone (iPTH) [mg/dl] were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
liver enzymes activity assessmentDiagnostic test
activity of:
- alanine transaminase (ALT) [U/l];
- aspartate transaminase (AST) [U/l];
- alkaline phosphatase (ALP) [U/l] were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
total protein and albuminDiagnostic test
- total protein (TP) [g/dl];
- albumin (ALB) [g/dl] were assessed in the serum by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
creatinine and ureaDiagnostic test
- creatinine in the serum [mg/dl] - the assay is based on the reaction of creatinine with sodium picrate as described by Jaffe (Jaffes' colorimetric method) - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA;
- urea [mg/dl] in the serum - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
selected parameters of oxidative stress (2)Diagnostic test
myeloperoxidase (MPO) [ng/ml] in the serum- was determined by the ELISA method using the Quantikine Human MPO test by R\&D Systems kit, Canada.
selected parameters of oxidative stress (3) sRAGEDiagnostic test
soluble receptor for advanced glycation end products (sRAGE) [µg/mg protein] in the serum was tested with enzymatic immunoassay (Quantikine ELISA) using R\&D Systems kit, Canada.
selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groupsDiagnostic test
- methylglyoxal (MG) [µg/mg protein];
- carboxyethyle(lysine) (CEL) [µg/mg protein];
- carbamyl protein groups [µg/mg protein] were assessed in the serum by competitive enzyme immunoassay (competitive ELISA) using kits from Cell Biolabs Inc, USA.
selected electrolytes assessmentDiagnostic test
- potassium (K) [mmol/l];
- sodium (Na) [mmol/l];
- magnesium (Mg) [mg/dL] were assessed in the serum by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
NT-pro-brain natriuretic peptide (NT-proBNP)Diagnostic test
NT-proBNP [fmol/ml] - was analyzed in the serum by enzyme immunoassay using the Nt-proBNP kit from Biomedica, Slovakia.
estimated glomerular filtration rate (eGFR) calculationOther
eGFR [ml/min/1.73m^2] - according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 recommendations was calculated based on the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 x [creatinine concentration in mg/dl] - 1.154 x [age in years] - 0.203 x [0.724] for the female gender.
| Study group | Role | What they receive |
|---|---|---|
| PREDIALYSIS GROUP | (n = 48) - patients in the pre-dialysis period (stages G3b-G4 of chronic kidey disease (CKD)) with moderate or severe decrease in estimated glomerular filtration rate (eGFR) (eGFR 44-29 ml/min/1.73 m^2) Receives: Diagnostic Test: laboratory parameters - complete blood count; Other: body mass index (BMI) [kg/m^2] calculation; Diagnostic Test: selected parameters of oxidative stress (1); Diagnostic Test: metalloproteinases; Diagnostic Test: parameters of lipids metabolism in the serum; Diagnostic Test: parameters of iron metabolism; Diagnostic Test: selected inflammatory markers; Device: carotid intima-media thickness (IMT); Device: non-invasive cardiological examinations; Device: vessel stiffness assessment; Other: cardiovascular (CV)-related death recording during 2-year follow-up; Diagnostic Test: glucose (Glu); Diagnostic Test: klotho; Diagnostic Test: fibroblast growth factor 23 (FGF-23); Diagnostic Test: parameters of calcium and phosphate metabolism; Diagnostic Test: liver enzymes activity assessment; Diagnostic Test: total protein and albumin; Diagnostic Test: creatinine and urea; Diagnostic Test: selected parameters of oxidative stress (2); Diagnostic Test: selected parameters of oxidative stress (3) sRAGE; Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups; Diagnostic Test: selected electrolytes assessment; Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP); Other: estimated glomerular filtration rate (eGFR) calculation | |
| END-STAGE RENAL DISEASE (ESRD) GROUP | Patients with ESRD (n=106) - (eGFR <15 ml/min /1.73 m^2) undergoing renal replacement therapy have formed this group.
Depending on the method of renal replacement therapy used, two subgroups have been distinguished: (1) peritoneal dialysis (PD) subgroup (n=35) including patients treated by peritoneal dialysis. In this subgroup, due to the treatment technique, two groups have been distinguished, a group (n=15) treated with the automatic peritoneal dialysis (APD) technique and a group (n = 20) using the technique of continuous cycling peritoneal dialysis (CCPD), (2) hemodialysis (HD) subgroup (n = 71) including patients treated with repeated hemodialysis. The duration of hemodialysis was at least 10 hours/week using standard bicarbonate dialysis fluids and polysulfone low-flux dialyzers. The blood flow during hemodialysis was 200-350 ml/min, with an average dialysis fluid flow of 500 ml/min. Receives: Diagnostic Test: laboratory parameters - complete blood count; Other: body mass index (BMI) [kg/m^2] calculation; Diagnostic Test: selected parameters of oxidative stress (1); Diagnostic Test: metalloproteinases; Diagnostic Test: parameters of lipids metabolism in the serum; Diagnostic Test: parameters of iron metabolism; Diagnostic Test: selected inflammatory markers; Device: carotid intima-media thickness (IMT); Device: non-invasive cardiological examinations; Device: vessel stiffness assessment; Other: cardiovascular (CV)-related death recording during 2-year follow-up; Diagnostic Test: glucose (Glu); Diagnostic Test: klotho; Diagnostic Test: fibroblast growth factor 23 (FGF-23); Diagnostic Test: parameters of calcium and phosphate metabolism; Diagnostic Test: liver enzymes activity assessment; Diagnostic Test: total protein and albumin; Diagnostic Test: creatinine and urea; Diagnostic Test: selected parameters of oxidative stress (2); Diagnostic Test: selected parameters of oxidative stress (3) sRAGE; Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups; Diagnostic Test: selected electrolytes assessment; Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP); Other: estimated glomerular filtration rate (eGFR) calculation | |
| CARDIOLOGY (CARD) GROUP | CARD group (n = 37) - patients with at least one history of a cardiovascular event, admitted to hospital for elective angiography, without any signs of impaired kidney function.
The studies in this group were conducted to check the changes that occur as a result of cardiovascular disease (CVD) but without kidney disease. Receives: Diagnostic Test: laboratory parameters - complete blood count; Other: body mass index (BMI) [kg/m^2] calculation; Diagnostic Test: selected parameters of oxidative stress (1); Diagnostic Test: metalloproteinases; Diagnostic Test: parameters of lipids metabolism in the serum; Diagnostic Test: parameters of iron metabolism; Diagnostic Test: selected inflammatory markers; Device: carotid intima-media thickness (IMT); Device: non-invasive cardiological examinations; Device: vessel stiffness assessment; Other: cardiovascular (CV)-related death recording during 2-year follow-up; Diagnostic Test: glucose (Glu); Diagnostic Test: klotho; Diagnostic Test: fibroblast growth factor 23 (FGF-23); Diagnostic Test: parameters of calcium and phosphate metabolism; Diagnostic Test: liver enzymes activity assessment; Diagnostic Test: total protein and albumin; Diagnostic Test: creatinine and urea; Diagnostic Test: selected parameters of oxidative stress (2); Diagnostic Test: selected parameters of oxidative stress (3) sRAGE; Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups; Diagnostic Test: selected electrolytes assessment; Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP); Other: estimated glomerular filtration rate (eGFR) calculation | |
| Chronic kidney disease (CKD) 1-2 GROUP | CKD1-2 (n=29) (stage G1-G2 CKD) with mild decrease in eGFR (eGFR >90-60 ml/min/1.73 m^2)
The studies in this group were performed to disclose the changes that occur as a consequence of the beginning of kidney function deterioration. Receives: Diagnostic Test: laboratory parameters - complete blood count; Other: body mass index (BMI) [kg/m^2] calculation; Diagnostic Test: selected parameters of oxidative stress (1); Diagnostic Test: metalloproteinases; Diagnostic Test: parameters of lipids metabolism in the serum; Diagnostic Test: parameters of iron metabolism; Diagnostic Test: selected inflammatory markers; Device: carotid intima-media thickness (IMT); Device: non-invasive cardiological examinations; Device: vessel stiffness assessment; Other: cardiovascular (CV)-related death recording during 2-year follow-up; Diagnostic Test: glucose (Glu); Diagnostic Test: klotho; Diagnostic Test: fibroblast growth factor 23 (FGF-23); Diagnostic Test: parameters of calcium and phosphate metabolism; Diagnostic Test: liver enzymes activity assessment; Diagnostic Test: total protein and albumin; Diagnostic Test: creatinine and urea; Diagnostic Test: selected parameters of oxidative stress (2); Diagnostic Test: selected parameters of oxidative stress (3) sRAGE; Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups; Diagnostic Test: selected electrolytes assessment; Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP); Other: estimated glomerular filtration rate (eGFR) calculation | |
| Healthy volunteers (HV) | HV (n = 32) - this group was composed of healthy people, with no evidence of impairment in renal function and cardiovascular disorders in the history and at the time of enrollment in the study. Receives: Diagnostic Test: laboratory parameters - complete blood count; Other: body mass index (BMI) [kg/m^2] calculation; Diagnostic Test: selected parameters of oxidative stress (1); Diagnostic Test: metalloproteinases; Diagnostic Test: parameters of lipids metabolism in the serum; Diagnostic Test: parameters of iron metabolism; Diagnostic Test: selected inflammatory markers; Device: carotid intima-media thickness (IMT); Device: non-invasive cardiological examinations; Device: vessel stiffness assessment; Other: cardiovascular (CV)-related death recording during 2-year follow-up; Diagnostic Test: glucose (Glu); Diagnostic Test: klotho; Diagnostic Test: fibroblast growth factor 23 (FGF-23); Diagnostic Test: parameters of calcium and phosphate metabolism; Diagnostic Test: liver enzymes activity assessment; Diagnostic Test: total protein and albumin; Diagnostic Test: creatinine and urea; Diagnostic Test: selected parameters of oxidative stress (2); Diagnostic Test: selected parameters of oxidative stress (3) sRAGE; Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups; Diagnostic Test: selected electrolytes assessment; Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP); Other: estimated glomerular filtration rate (eGFR) calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic test: basic biochemical parameters: complete blood count - hemoglobin (HGB)
hemoglobin (HGB) [g/dl] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Measured: 3 years
Diagnostic test: basic biochemical parameters: complete blood count - red blood cell count (RBC)
red blood cell count (RBC) [10^12/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Measured: 3 years
Diagnostic test: basic biochemical parameters: complete blood count - hematocrit (HCT)
hematocrit (HCT) [l/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Measured: 3 years
Diagnostic test: basic biochemical parameters: complete blood count - white blood cell count (WBC)
white blood cells (WBC) [10^9/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Measured: 3 years
Diagnostic test: basic biochemical parameters: complete blood count - platelet count (PLT)
platelet count (PLT) [10^9/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Measured: 3 years
Diagnostic test: glucose (Glu)
glucose (Glu) [mg/dl] concentration in the serum was assessed by the routine technique using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: urea
urea [mg/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: creatinine
creatinine [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA (based on Jaffes' colorimetric method - the assay is based on the reaction of creatinine with sodium picrate as described by Jaffe).
Measured: 3 years
Estimated glomerular filtration rate (eGFR) [ml/min/1.73m^2] calculation
eGFR - according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 recommendations was calculated based on the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 x [creatinine concentration in mg/dl] - 1.154 x [age in years] - 0.203 x [0.724] for the female gender.
Measured: 3 years
Body mass index (BMI) [kg/m^2] calculation
Body mass index (BMI) - [kg/m^2] was calculated by dividing a person's weight (post-HD weight in HD group) [kg] by the squared their body height [m].
Measured: 3 years
Diagnostic test: parameters of lipids metabolism in the serum - total cholesterol (T-C)
total cholesterol (T-C) [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: parameters of lipids metabolism in the serum - high-density lipoprotein cholesterol (HDL-C)
high-density lipoprotein cholesterol (HDL-C) [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: parameters of lipids metabolism in the serum low-density lipoprotein cholesterol (LDL-C).
low-density lipoprotein (LDL-C) cholesterol concentration in the serum was determined from Friedewals' equation (LDL-C [mg/dl] = total cholesterol (T-C) [mg/dl] - HDL-C [mg/dl] - TG[mg/dl]/5).
It was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: parameters of lipids metabolism in the serum - triglycerides (TG)
triglycerides (TG) [mg/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: liver enzymes activity assessment - aspartate transaminase (AST)
activity of aspartate transaminase (AST) [U/l]; was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: liver enzymes activity assessment - alanine transaminase (ALT)
activity of alanine transaminase (ALT) [U/l] was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: liver enzymes activity assessment - alkaline phosphatase (ALP) [U/l]
activity of alkaline phosphatase (ALP) [U/l] was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: total protein (TP)
total protein (TP) [g/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: albumin(ALB)
albumin (ALB) [g/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: parameters of iron metabolism - iron
iron concentration [mg/dl] in the serum - was assessed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA;
Measured: 3 years
Diagnostic test: parameters of iron metabolism - total iron-binding capacity (TIBC)
total iron-binding capacity (TIBC) [mg/dl] - was determined with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: parameters of iron metabolism - the unsaturated iron-binding capacity (UIBC)
unsaturated iron-binding capacity (UIBC) [mg/dl] was determined by an equation in which iron [mg/dl] concentration in plasma is subtracted from TIBC [mg/dl].
Measured: 3 years
Diagnostic test: parameters of iron metabolism - ferritin
ferritin [ng/ml] concentration in the serum was determined with the Modular E-170 biochemical analyzer from Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: total and ionized calcium
total and ionized calcium [mg/dl] serum concentrations were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: phosphate
phosphate [mg/dl] serum concentration was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: intact parathormone (iPTH)
intact parathormone (iPTH) [mg/dl] serum concentration was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: klotho (KL)
klotho (KL) [ng/ml] serum concentration was analyzed by Human KL(Klotho) [ng/ml] ELISA Kit, Shanghai Sunred Biological Technology Co kit, China.
Measured: 3 years
Diagnostic test: fibroblast growth factor 23 (FGF-23)
fibroblast growth factor 23 (FGF-23) [pg/ml] serum concentration was analyzed using Human FGF-23 ELISA Kit, Sigma-Aldrich, USA.
Measured: 3 years
Diagnostic test: selected electrolytes assessment in the serum: potassium (K) and sodium (Na)
Electrolytes: potassium (K) [mmol/l] and sodium (Na) [mmol/l] serum concentrations were assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: selected electrolytes assessment in the serum: magnesium
magnesium (Mg) [mg/dl] serum concentration was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - 3-nitrotyrosine (3-NT)
Serum concentration of 3-nitrotyrosine (3-NT) [µmol/mg protein] was determined with the enzyme immunoassay method (ELISA) for 3NT using Shanghai Sunred Biological Technology Co kits, China.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - advanced glycation ends products (AGE)
Serum concentration of advanced glycation ends products (AGE) [µg/mg protein] was determined with the enzyme immunoassay method (ELISA) for AGE using Shanghai Sunred Biological Technology Co kits, China.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - carboxymethyle(lysine) (CML)
Serum concentration of carboxymethyle(lysine) (CML) [µg/mg protein] was determined with the enzyme immunoassay method (ELISA) for CML using Shanghai Sunred Biological Technology Co kits, China.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - advanced oxidation protein products (AOPP)
Serum concentration of advanced oxidation protein products (AOPP) [µmol/mg protein] was determined with the enzyme immunoassay method (ELISA) for AOPP using Shanghai Sunred Biological Technology Co kits, China.
Measured: 3 years
Diagnostic test: metalloproteinases - metalloproteinase 9 (MMP-9)
metalloproteinase 9 (MMP-9) [ng/ml] concentration in the serum was determined by the ELISA method using the Quantikine Human MMP-9 (total) kit, by R\&D Systems, Canada.
Measured: 3 years
Diagnostic test: metalloproteinases - tissue inhibitor of metalloproteinase 1 (TIMP-1)
tissue inhibitor of metalloproteinase 1 (TIMP-1) [ng/ml] concentration in the serum - was determined by the ELISA method using the Quantikine Human TIMP-1 kit, manufactured by R\&D Systems, Canada.
Measured: 3 years
The MMP-9/TIMP-1 ratio assessment
the MMP-9/TIMP-1 ratio was calculated by the quotient of the MMP-9 [ng/ml] and the TIMP-1 [ng/ml] concentration.
Measured: 3 years
Diagnostic test: selected inflammatory markers - high-sensivity C-reactive protein (hsCRP)
high-sensitivity C-reactive protein (hsCRP) [mg/l] concentration in the serum was measured using DADE Behring, USA, and the DADE nephelometer Behring Analyzer II.
Measured: 3 years
Diagnostic test: selected inflammatory markers - neopterin
neopterin [nmol/l] serum concentration was determined by using the Neopterin ELISA kit, DRG International, Inc., USA.
Measured: 3 years
Diagnostic Test: selected inflammatory markers - interleukin 18 (IL-18)
interleukin 18 (IL-18) [pg/ml] concentration in the serum was determined by Colorimetric Sandwich ELISA, Quantikine Human IL-18 R\&D Inc., USA.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - myeloperoxidase (MPO)
myeloperoxidase (MPO) [ng/ml] in the serum - was determined by the ELISA method using the Quantikine Human MPO test by R\&D Systems kit, Canada.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - methylglyoxal (MG)
methylglyoxal (MG) [µg/mg protein] concentration in the serum was assessed by competitive enzyme immunoassay (competitive ELISA) using MG kits from Cell Biolabs Inc, USA.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - carboxyethyle(lysine) (CEL) [µg/mg protein]
carboxyethyle(lysine) (CEL) [µg/mg protein] concentration in the serum was assessed by competitive enzyme immunoassay (competitive ELISA) using CEL kits from Cell Biolabs Inc, USA.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - carbamyl protein groups [µg/mg protein]
carbamyl protein groups [µg/mg protein] concentration in the serum were assessed by competitive enzyme immunoassay (competitive ELISA) using carbamyl protein groups kits from Cell Biolabs Inc, USA.
Measured: 3 years
Diagnostic test: selected parameters of oxidative stress - soluble receptor for advanced glycation end products (sRAGE)
soluble receptor for advanced glycation end products (sRAGE) [µg/mg protein] concentration in the serum was tested with enzymatic immunoassay (Quantikine ELISA) using R\&D Systems sRAGE kit, Canada.
Measured: 3 years
Non-invasive cardiological examinations (1) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - blood pressures
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded:
- peripheral systolic blood pressure (sSBP) [mmHg];
- peripheral diastolic blood pressure (pDBP)[mm Hg];
- peripheral mean arterial pressure (pMAP) [mm Hg];
- peripheral end-systolic pressure (pESP) [mm Hg];
- central systolic blood pressure (cSBP) [mm Hg];
- central diastolic blood pressure (cDBP) [mm Hg];
- central mean arterial pressure (cMAP) [mm Hg];
- entral augmented pressure (cAP) [mm Hg];
- central mean pressure of diastole (cMPD) [mm Hg];
- central mean pressure of systole (cMPS)[mm Hg];
- central end-systolic pressure (cESP)[mm Hg]
Measured: 3 years
Non-invasive cardiological examinations (2) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - heart rate (HR)
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded:
- heart rate (HR) in beats per minute [bpm]
Measured: 3 years
Non-invasive cardiological examinations (3) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - ejection duration (ED)
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded:
- ejection duration (ED) in milliseconds [msec]
Measured: 3 years
Device: carotid intima-media thickness (IMT)
Carotid intima-media thickness (IMT) [mm] was measured by The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer.
Two longitudinal projections were assessed (anterolateral and posterolateral). The distal 1 cm of the common carotid artery just proximal to the bulb was measured by means of a computer analysis system (Medical Imaging Applications, LLC).
Measured: 3 years
Device: vessel stiffness assessments - reflection index (RI)
The following parameter of vessel stiffness was assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom):
- reflection index (RI) in percentages [%].
Measured: 3 years
Device: vessel stiffness assessments - vascular stiffness index (SI)
The following parameter of vessel stiffness was assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom):
-vascular stiffness index (SI) [m/s].
Measured: 3 years
Device: vessel stiffness assessments - peripheral (pPP) and central pulse pressure (cPP) [mm Hg]
The following parameters of vessel stiffness were assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom):
- peripheral pulse pressure (pPP) [mm Hg];
- central pulse pressure (cPP) [mm Hg]
Measured: 3 years
Device: vessel stiffness assessments - peripheral pulse pressure/central pulse pressure (pPP/cPP) ratio
Peripheral pulse pressure/central pulse pressure (pPP/cPP) ratio was assessed by dividing peripheral pulse pressure (pPP) [mm Hg] by central pulse pressure (cPP) [mm Hg].
Measured: 3 years
Cardiovascular (CV)-related death recording during 2-year follow-up
During a 2-year follow-up from the enrollment to this study, CV-related fatal incidents history has been recorded for each subject separately. The primary endpoint was fatal acute myocardial infarction (AMI) or acute ischemic stroke or any unexpected or sudden death only if autopsy proved CV-related. If there was doubt about the cause of death or there was no contact with the patient during the two years from study enrollment, that patient was excluded and not considered further.
Measured: 2 years for each person qualified for the study
Diagnostic test: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [fmol/ml] concentration in the serum was analyzed by enzyme immunoassay using the Nt-proBNP kit from Biomedica, Slovakia.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start25 Mar 2016
- Primary completion10 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis of ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorota Formanowicz, Poznan University of Medical Sciences
- Investigators
- Dorota Formanowicz, MD, PhD, Principal investigator, Poznan University of Mediccal Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214872
- Sponsor's protocol ID
- PoznanUMS_DF2
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Twardawa M, Formanowicz P, Formanowicz D. Chronic Kidney Disease as a Cardiovascular Disorder-Tonometry Data Analyses. Int J Environ Res Public Health. 2022 Sep 28;19(19):12339. doi: 10.3390/ijerph191912339.
PubMed 36231682Kasprzak L, Twardawa M, Formanowicz P, Formanowicz D. The Mutual Contribution of 3-NT, IL-18, Albumin, and Phosphate Foreshadows Death of Hemodialyzed Patients in a 2-Year Follow-Up. Antioxidants (Basel). 2022 Feb 11;11(2):355. doi: 10.3390/antiox11020355.
PubMed 35204237
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Selected Factors on the Cardiovascular System in Patients With Different Chronic Kidney Disease Stages
- ClinicalTrials.gov ID
- NCT05214872
- Acronym / sponsor ID
- PoznanUMS_DF2
- Conditions
- Atherosclerosis of Artery, Inflammation, Chronic Kidney Diseases, Dialysis; Complications, Cardiovascular Diseases
- Keywords
- risk factors, chronic kidney disease, inflammation, oxidative stress, atherosclerosis, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD), is characterized by accelerated development of atherosclerosis and advanced remodelling of vessels and the heart. It is associated with many factors, including inflammation, arterial hypertension, hyperlipidemia, hyperhomocysteinemia, secondary hyperparathyroidism, and oxidative stress. Hypertension is one of the most critical risk factors for cardiovascular complications. It leads to the formation of structural changes in the vascular system: it impairs the activity of the endothelium, causes hypertrophy and remodelling of the vascular wall, reduces the susceptibility of the vessels and accelerates the development of atherosclerosis. This study aimed to identify the processes and their representative markers, the concentration of which in the serum may reflect the cardiovascular system status and can predict the increased mortality in HD patients.
Detailed description
Chronic Kidney Disease has a significant impact on the cardiovascular system. From many different complications of CKD, one to mention is arterial stiffness. This disorder results from many pathologies, including inflammation, arterial hypertension, carbohydrate metabolic disorders, lipid disorders, vascular calcification, chronic inflammation, and oxidative stress.
The main goal of this study was to analyze the mechanisms leading to the increased tendency to cardiovascular disturbances in CKD, with particular focus on the parameters of oxidative stress, inflammation and the results of imaging examinations (intima-media thickness (IMT) assessments) and other non-invasive cardiological examinations based on the results using the Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom) The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer.
Besides, studied participants were followed 2 years after enrollment to study for recording cardiovascular-related death.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PREDIALYSIS GROUP | – | Diagnostic Test: laboratory parameters - complete blood count, Other: body mass index (BMI) [kg/m^2] calculation, Diagnostic Test: selected parameters of oxidative stress (1), Diagnostic Test: metalloproteinases, Diagnostic Test: parameters of lipids metabolism in the serum, Diagnostic Test: parameters of iron metabolism, Diagnostic Test: selected inflammatory markers, Device: carotid intima-media thickness (IMT), Device: non-invasive cardiological examinations, Device: vessel stiffness assessment, Other: cardiovascular (CV)-related death recording during 2-year follow-up, Diagnostic Test: glucose (Glu), Diagnostic Test: klotho, Diagnostic Test: fibroblast growth factor 23 (FGF-23), Diagnostic Test: parameters of calcium and phosphate metabolism, Diagnostic Test: liver enzymes activity assessment, Diagnostic Test: total protein and albumin, Diagnostic Test: creatinine and urea, Diagnostic Test: selected parameters of oxidative stress (2), Diagnostic Test: selected parameters of oxidative stress (3) sRAGE, Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups, Diagnostic Test: selected electrolytes assessment, Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP), Other: estimated glomerular filtration rate (eGFR) calculation(n = 48) - patients in the pre-dialysis period (stages G3b-G4 of chronic kidey disease (CKD)) with moderate or severe decrease in estimated glomerular filtration rate (eGFR) (eGFR 44-29 ml/min/1.73 m^2) |
| END-STAGE RENAL DISEASE (ESRD) GROUP | – | Diagnostic Test: laboratory parameters - complete blood count, Other: body mass index (BMI) [kg/m^2] calculation, Diagnostic Test: selected parameters of oxidative stress (1), Diagnostic Test: metalloproteinases, Diagnostic Test: parameters of lipids metabolism in the serum, Diagnostic Test: parameters of iron metabolism, Diagnostic Test: selected inflammatory markers, Device: carotid intima-media thickness (IMT), Device: non-invasive cardiological examinations, Device: vessel stiffness assessment, Other: cardiovascular (CV)-related death recording during 2-year follow-up, Diagnostic Test: glucose (Glu), Diagnostic Test: klotho, Diagnostic Test: fibroblast growth factor 23 (FGF-23), Diagnostic Test: parameters of calcium and phosphate metabolism, Diagnostic Test: liver enzymes activity assessment, Diagnostic Test: total protein and albumin, Diagnostic Test: creatinine and urea, Diagnostic Test: selected parameters of oxidative stress (2), Diagnostic Test: selected parameters of oxidative stress (3) sRAGE, Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups, Diagnostic Test: selected electrolytes assessment, Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP), Other: estimated glomerular filtration rate (eGFR) calculationPatients with ESRD (n=106) - (eGFR <15 ml/min /1.73 m^2) undergoing renal replacement therapy have formed this group. Depending on the method of renal replacement therapy used, two subgroups have been distinguished: (1) peritoneal dialysis (PD) subgroup (n=35) including patients treated by peritoneal dialysis. In this subgroup, due to the treatment technique, two groups have been distinguished, a group (n=15) treated with the automatic peritoneal dialysis (APD) technique and a group (n = 20) using the technique of continuous cycling peritoneal dialysis (CCPD), (2) hemodialysis (HD) subgroup (n = 71) including patients treated with repeated hemodialysis. The duration of hemodialysis was at least 10 hours/week using standard bicarbonate dialysis fluids and polysulfone low-flux dialyzers. The blood flow during hemodialysis was 200-350 ml/min, with an average dialysis fluid flow of 500 ml/min. |
| CARDIOLOGY (CARD) GROUP | – | Diagnostic Test: laboratory parameters - complete blood count, Other: body mass index (BMI) [kg/m^2] calculation, Diagnostic Test: selected parameters of oxidative stress (1), Diagnostic Test: metalloproteinases, Diagnostic Test: parameters of lipids metabolism in the serum, Diagnostic Test: parameters of iron metabolism, Diagnostic Test: selected inflammatory markers, Device: carotid intima-media thickness (IMT), Device: non-invasive cardiological examinations, Device: vessel stiffness assessment, Other: cardiovascular (CV)-related death recording during 2-year follow-up, Diagnostic Test: glucose (Glu), Diagnostic Test: klotho, Diagnostic Test: fibroblast growth factor 23 (FGF-23), Diagnostic Test: parameters of calcium and phosphate metabolism, Diagnostic Test: liver enzymes activity assessment, Diagnostic Test: total protein and albumin, Diagnostic Test: creatinine and urea, Diagnostic Test: selected parameters of oxidative stress (2), Diagnostic Test: selected parameters of oxidative stress (3) sRAGE, Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups, Diagnostic Test: selected electrolytes assessment, Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP), Other: estimated glomerular filtration rate (eGFR) calculationCARD group (n = 37) - patients with at least one history of a cardiovascular event, admitted to hospital for elective angiography, without any signs of impaired kidney function. The studies in this group were conducted to check the changes that occur as a result of cardiovascular disease (CVD) but without kidney disease. |
| Chronic kidney disease (CKD) 1-2 GROUP | – | Diagnostic Test: laboratory parameters - complete blood count, Other: body mass index (BMI) [kg/m^2] calculation, Diagnostic Test: selected parameters of oxidative stress (1), Diagnostic Test: metalloproteinases, Diagnostic Test: parameters of lipids metabolism in the serum, Diagnostic Test: parameters of iron metabolism, Diagnostic Test: selected inflammatory markers, Device: carotid intima-media thickness (IMT), Device: non-invasive cardiological examinations, Device: vessel stiffness assessment, Other: cardiovascular (CV)-related death recording during 2-year follow-up, Diagnostic Test: glucose (Glu), Diagnostic Test: klotho, Diagnostic Test: fibroblast growth factor 23 (FGF-23), Diagnostic Test: parameters of calcium and phosphate metabolism, Diagnostic Test: liver enzymes activity assessment, Diagnostic Test: total protein and albumin, Diagnostic Test: creatinine and urea, Diagnostic Test: selected parameters of oxidative stress (2), Diagnostic Test: selected parameters of oxidative stress (3) sRAGE, Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups, Diagnostic Test: selected electrolytes assessment, Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP), Other: estimated glomerular filtration rate (eGFR) calculationCKD1-2 (n=29) (stage G1-G2 CKD) with mild decrease in eGFR (eGFR >90-60 ml/min/1.73 m^2) The studies in this group were performed to disclose the changes that occur as a consequence of the beginning of kidney function deterioration. |
| Healthy volunteers (HV) | – | Diagnostic Test: laboratory parameters - complete blood count, Other: body mass index (BMI) [kg/m^2] calculation, Diagnostic Test: selected parameters of oxidative stress (1), Diagnostic Test: metalloproteinases, Diagnostic Test: parameters of lipids metabolism in the serum, Diagnostic Test: parameters of iron metabolism, Diagnostic Test: selected inflammatory markers, Device: carotid intima-media thickness (IMT), Device: non-invasive cardiological examinations, Device: vessel stiffness assessment, Other: cardiovascular (CV)-related death recording during 2-year follow-up, Diagnostic Test: glucose (Glu), Diagnostic Test: klotho, Diagnostic Test: fibroblast growth factor 23 (FGF-23), Diagnostic Test: parameters of calcium and phosphate metabolism, Diagnostic Test: liver enzymes activity assessment, Diagnostic Test: total protein and albumin, Diagnostic Test: creatinine and urea, Diagnostic Test: selected parameters of oxidative stress (2), Diagnostic Test: selected parameters of oxidative stress (3) sRAGE, Diagnostic Test: selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups, Diagnostic Test: selected electrolytes assessment, Diagnostic Test: NT-pro-brain natriuretic peptide (NT-proBNP), Other: estimated glomerular filtration rate (eGFR) calculationHV (n = 32) - this group was composed of healthy people, with no evidence of impairment in renal function and cardiovascular disorders in the history and at the time of enrollment in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 252 people have been enrolled on the study, including 106 consecutive dialyzed patients (HD group), treated in 2016-2018 at the Nephrology Outpatient Clinic and the Clinical Hospital's Dialysis Center. H. Święcickiego in Poznań; 37 32 healthy participants (control group), serving as a comparative group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory parameters - complete blood countthe complete blood count was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA): * hemoglobin (HGB) [g/dl]; * red blood count (RBC) [10^12/l]; * hematocrit (HCT) [l/l]; * white blood cells (WBC) [10^9/l]; * platelet count (PLT) [10^9/l] | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| body mass index (BMI) [kg/m^2] calculationbody mass index (BMI) [kg/m^2] was calculated by dividing a person's weight (post-HD weight in HD group) [kg] by the squared their body height [m] | Other | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected parameters of oxidative stress (1)Serum concentration of: * advanced glycation ends products (AGE) [µg/mg protein]; * 3-nitrotyrosine (3-NT) [µmol/mg protein]; * advanced oxidation protein products (AOPP) [µmol/mg protein]; * carboxymethyle(lysine) (CML) [µg/mg protein] were determined with the enzyme immunoassay methods (ELISA) using Shanghai Sunred Biological Technology Co kits, China. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| metalloproteinasesmetalloproteinases in the serum [ng/ml]: * metalloproteinase 9 (MMP-9) in the serum was determined by the ELISA method using the Quantikine Human MMP-9 (total) kit, by R\&D Systems, Canada; * tissue inhibitor of metalloproteinase 1 (TIMP-1) in the serum - was determined by the ELISA method using the Quantikine Human TIMP-1 kit, manufactured by R\&D Systems, Canada; * the MMP-9/TIMP-1 ratio was calculated by the quotient of the MMP-9 and the TIMP-1 concentration. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| parameters of lipids metabolism in the serum* total cholesterol (T-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA; * low-density lipoprotein cholesterol (LDL-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA; * high-density lipoprotein cholesterol (HDL-C) [mg/dl] - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA; * triglycerides (TG) [mg/dl] - were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA; * the concentration of low-density lipoprotein (LDL-C) cholesterol - was determined from Friedewalds' equation (LDL-C [mg/dl] = total cholesterol (T-C) [mg/dl]- HDL-C [mg/dl]- TG[mg/dl]/5). | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| parameters of iron metabolism* iron concentration [mg/dl] - was analyzed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA; * total iron-binding capacity (TIBC) [mg/dl] - was analyzed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA; * the unsaturated iron-binding capacity (UIBC) [mg/dl] was determined by an equation in which iron concentration in plasma is subtracted from TIBC [mg/dl]; * ferritin [ng/ml] concentration was determined with the Modular E-170 biochemical analyzer from Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected inflammatory markers* high-sensitivity C-reactive protein (hsCRP) [mg/l] was measured using DADE Behring, USA and the DADE nephelometer Behring Analyzer II; * neopterin [nmol/l] was determined by using the Neopterin ELISA kit, DRG International, Inc., USA; * interleukin 18 (IL-18) [pg/ml] concentration was determined by Colorimetric Sandwich ELISA, Quantikine Human IL-18 R\&D Inc., USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| carotid intima-media thickness (IMT)carotid intima-media thickness (IMT) [mm] was measured by The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer. Two longitudinal projections were assessed (anterolateral and posterolateral). The distal 1 cm of the common carotid artery just proximal to the bulb was measured by means of a computer analysis system (Medical Imaging Applications, LLC). | Device | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| non-invasive cardiological examinationsFor non-invasive cardiological examinations, the Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) were used. Main assessed variables: heart rate (HR) [beats per minute [bpm]]; ejection duration (ED) [millisecons]; peripheral systolic (pSBP) and diastolic blood pressure (pDBP) [mm Hg]; peripheral mean arterial pressure (pMAP) [mm Hg]; peripheral end-systolic pressure (pESP) [mm Hg]; central systolic (cSBP) and diastolic blood pressure (cDBP) [mm Hg]; central mean arterial pressure (cMAP) [mm Hg]; central augmented pressure (cAP) [mmHg]; central mean pressure of diastole (cMPD)[mm Hg]; central mean pressure of systole (cMPS) [mm Hg]; central end-systolic pressure (cESP) [mm Hg]. | Device | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| vessel stiffness assessmentThe following parameters of vessel stiffness were assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom): * reflection index (RI) [in percentages [%]]; * vascular stiffness index (SI) [m/s]; * peripheral pulse pressure (pPP) [mm Hg]; * central puls pressure (cPP) [mm Hg] * peripheral pulse pressure/central pulse pressure (pPP/cPP ratio). | Device | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| cardiovascular (CV)-related death recording during 2-year follow-upDuring a 2-year follow-up from the enrollment to this study, CV-related fatal incidents history has been recorded for each subject separately. The primary endpoint was fatal acute myocardial infarction (AMI) or acute ischemic stroke or any unexpected or sudden death only if autopsy proved CV-related. If there was doubt about the cause of death or there was no contact with the patient during the two years from study enrollment, that patient was excluded and not considered further. | Other | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| glucose (Glu)glucose (Glu) [mg/dl] was assessed in the serum by a routine technique using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| klothoklotho [ng/ml] - was analyzed in the serum by Human KL(Klotho) [ng/ml] ELISA Kit, Shanghai Sunred Biological Technology Co kit, China. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| fibroblast growth factor 23 (FGF-23)FGF-23 [pg/ml] - was analyzed in rhe serum using Human FGF-23 ELISA Kit, Sigma-Aldrich, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| parameters of calcium and phosphate metabolism* total and ionized calcium [mg/dl], * phosphate [mg/dl], * intact parathormone (iPTH) [mg/dl] were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| liver enzymes activity assessmentactivity of: * alanine transaminase (ALT) [U/l]; * aspartate transaminase (AST) [U/l]; * alkaline phosphatase (ALP) [U/l] were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| total protein and albumin* total protein (TP) [g/dl]; * albumin (ALB) [g/dl] were assessed in the serum by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| creatinine and urea* creatinine in the serum [mg/dl] - the assay is based on the reaction of creatinine with sodium picrate as described by Jaffe (Jaffes' colorimetric method) - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA; * urea [mg/dl] in the serum - was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected parameters of oxidative stress (2)myeloperoxidase (MPO) [ng/ml] in the serum- was determined by the ELISA method using the Quantikine Human MPO test by R\&D Systems kit, Canada. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected parameters of oxidative stress (3) sRAGEsoluble receptor for advanced glycation end products (sRAGE) [µg/mg protein] in the serum was tested with enzymatic immunoassay (Quantikine ELISA) using R\&D Systems kit, Canada. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected parameters of oxidative stress (4) MG, CEL, carbamyl protein groups* methylglyoxal (MG) [µg/mg protein]; * carboxyethyle(lysine) (CEL) [µg/mg protein]; * carbamyl protein groups [µg/mg protein] were assessed in the serum by competitive enzyme immunoassay (competitive ELISA) using kits from Cell Biolabs Inc, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| selected electrolytes assessment* potassium (K) [mmol/l]; * sodium (Na) [mmol/l]; * magnesium (Mg) [mg/dL] were assessed in the serum by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| NT-pro-brain natriuretic peptide (NT-proBNP)NT-proBNP [fmol/ml] - was analyzed in the serum by enzyme immunoassay using the Nt-proBNP kit from Biomedica, Slovakia. | Diagnostic test | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
| estimated glomerular filtration rate (eGFR) calculationeGFR [ml/min/1.73m^2] - according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 recommendations was calculated based on the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 x [creatinine concentration in mg/dl] - 1.154 x [age in years] - 0.203 x [0.724] for the female gender. | Other | CARDIOLOGY (CARD) GROUP, Chronic kidney disease (CKD) 1-2 GROUP, END-STAGE RENAL DISEASE (ESRD) GROUP, Healthy volunteers (HV), PREDIALYSIS GROUP |
Primary outcome
Diagnostic test: basic biochemical parameters: complete blood count - hemoglobin (HGB)
Time frame: 3 years
hemoglobin (HGB) [g/dl] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Diagnostic test: basic biochemical parameters: complete blood count - red blood cell count (RBC)
Time frame: 3 years
red blood cell count (RBC) [10^12/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Diagnostic test: basic biochemical parameters: complete blood count - hematocrit (HCT)
Time frame: 3 years
hematocrit (HCT) [l/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Diagnostic test: basic biochemical parameters: complete blood count - white blood cell count (WBC)
Time frame: 3 years
white blood cells (WBC) [10^9/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Diagnostic test: basic biochemical parameters: complete blood count - platelet count (PLT)
Time frame: 3 years
platelet count (PLT) [10^9/l] was analyzed using Sysmex K-4500 Automated Hematology Analyzer (by GMI Inc., USA).
Diagnostic test: glucose (Glu)
Time frame: 3 years
glucose (Glu) [mg/dl] concentration in the serum was assessed by the routine technique using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: urea
Time frame: 3 years
urea [mg/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: creatinine
Time frame: 3 years
creatinine [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA (based on Jaffes' colorimetric method - the assay is based on the reaction of creatinine with sodium picrate as described by Jaffe).
Estimated glomerular filtration rate (eGFR) [ml/min/1.73m^2] calculation
Time frame: 3 years
eGFR - according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 recommendations was calculated based on the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 x [creatinine concentration in mg/dl] - 1.154 x [age in years] - 0.203 x [0.724] for the female gender.
Body mass index (BMI) [kg/m^2] calculation
Time frame: 3 years
Body mass index (BMI) - [kg/m^2] was calculated by dividing a person's weight (post-HD weight in HD group) [kg] by the squared their body height [m].
Diagnostic test: parameters of lipids metabolism in the serum - total cholesterol (T-C)
Time frame: 3 years
total cholesterol (T-C) [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: parameters of lipids metabolism in the serum - high-density lipoprotein cholesterol (HDL-C)
Time frame: 3 years
high-density lipoprotein cholesterol (HDL-C) [mg/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: parameters of lipids metabolism in the serum low-density lipoprotein cholesterol (LDL-C).
Time frame: 3 years
low-density lipoprotein (LDL-C) cholesterol concentration in the serum was determined from Friedewals' equation (LDL-C [mg/dl] = total cholesterol (T-C) [mg/dl] - HDL-C [mg/dl] - TG[mg/dl]/5). It was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: parameters of lipids metabolism in the serum - triglycerides (TG)
Time frame: 3 years
triglycerides (TG) [mg/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: liver enzymes activity assessment - aspartate transaminase (AST)
Time frame: 3 years
activity of aspartate transaminase (AST) [U/l]; was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: liver enzymes activity assessment - alanine transaminase (ALT)
Time frame: 3 years
activity of alanine transaminase (ALT) [U/l] was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: liver enzymes activity assessment - alkaline phosphatase (ALP) [U/l]
Time frame: 3 years
activity of alkaline phosphatase (ALP) [U/l] was assessed in the serum by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: total protein (TP)
Time frame: 3 years
total protein (TP) [g/dl] concentration in the serum was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: albumin(ALB)
Time frame: 3 years
albumin (ALB) [g/dl] concentration in the serum was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: parameters of iron metabolism - iron
Time frame: 3 years
iron concentration [mg/dl] in the serum - was assessed with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA;
Diagnostic test: parameters of iron metabolism - total iron-binding capacity (TIBC)
Time frame: 3 years
total iron-binding capacity (TIBC) [mg/dl] - was determined with the Cobas Integra 400 plus biochemical analyzer from Roche Diagnostics, USA.
Diagnostic test: parameters of iron metabolism - the unsaturated iron-binding capacity (UIBC)
Time frame: 3 years
unsaturated iron-binding capacity (UIBC) [mg/dl] was determined by an equation in which iron [mg/dl] concentration in plasma is subtracted from TIBC [mg/dl].
Diagnostic test: parameters of iron metabolism - ferritin
Time frame: 3 years
ferritin [ng/ml] concentration in the serum was determined with the Modular E-170 biochemical analyzer from Roche Diagnostics, USA.
Diagnostic test: total and ionized calcium
Time frame: 3 years
total and ionized calcium [mg/dl] serum concentrations were assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: phosphate
Time frame: 3 years
phosphate [mg/dl] serum concentration was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: intact parathormone (iPTH)
Time frame: 3 years
intact parathormone (iPTH) [mg/dl] serum concentration was assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: klotho (KL)
Time frame: 3 years
klotho (KL) [ng/ml] serum concentration was analyzed by Human KL(Klotho) [ng/ml] ELISA Kit, Shanghai Sunred Biological Technology Co kit, China.
Diagnostic test: fibroblast growth factor 23 (FGF-23)
Time frame: 3 years
fibroblast growth factor 23 (FGF-23) [pg/ml] serum concentration was analyzed using Human FGF-23 ELISA Kit, Sigma-Aldrich, USA.
Diagnostic test: selected electrolytes assessment in the serum: potassium (K) and sodium (Na)
Time frame: 3 years
Electrolytes: potassium (K) [mmol/l] and sodium (Na) [mmol/l] serum concentrations were assessed by the routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: selected electrolytes assessment in the serum: magnesium
Time frame: 3 years
magnesium (Mg) [mg/dl] serum concentration was assessed by routine techniques using Cobas Integra 400 plus biochemical analyzer by Roche Diagnostics, USA.
Diagnostic test: selected parameters of oxidative stress - 3-nitrotyrosine (3-NT)
Time frame: 3 years
Serum concentration of 3-nitrotyrosine (3-NT) [µmol/mg protein] was determined with the enzyme immunoassay method (ELISA) for 3NT using Shanghai Sunred Biological Technology Co kits, China.
Diagnostic test: selected parameters of oxidative stress - advanced glycation ends products (AGE)
Time frame: 3 years
Serum concentration of advanced glycation ends products (AGE) [µg/mg protein] was determined with the enzyme immunoassay method (ELISA) for AGE using Shanghai Sunred Biological Technology Co kits, China.
Diagnostic test: selected parameters of oxidative stress - carboxymethyle(lysine) (CML)
Time frame: 3 years
Serum concentration of carboxymethyle(lysine) (CML) [µg/mg protein] was determined with the enzyme immunoassay method (ELISA) for CML using Shanghai Sunred Biological Technology Co kits, China.
Diagnostic test: selected parameters of oxidative stress - advanced oxidation protein products (AOPP)
Time frame: 3 years
Serum concentration of advanced oxidation protein products (AOPP) [µmol/mg protein] was determined with the enzyme immunoassay method (ELISA) for AOPP using Shanghai Sunred Biological Technology Co kits, China.
Diagnostic test: metalloproteinases - metalloproteinase 9 (MMP-9)
Time frame: 3 years
metalloproteinase 9 (MMP-9) [ng/ml] concentration in the serum was determined by the ELISA method using the Quantikine Human MMP-9 (total) kit, by R\&D Systems, Canada.
Diagnostic test: metalloproteinases - tissue inhibitor of metalloproteinase 1 (TIMP-1)
Time frame: 3 years
tissue inhibitor of metalloproteinase 1 (TIMP-1) [ng/ml] concentration in the serum - was determined by the ELISA method using the Quantikine Human TIMP-1 kit, manufactured by R\&D Systems, Canada.
The MMP-9/TIMP-1 ratio assessment
Time frame: 3 years
the MMP-9/TIMP-1 ratio was calculated by the quotient of the MMP-9 [ng/ml] and the TIMP-1 [ng/ml] concentration.
Diagnostic test: selected inflammatory markers - high-sensivity C-reactive protein (hsCRP)
Time frame: 3 years
high-sensitivity C-reactive protein (hsCRP) [mg/l] concentration in the serum was measured using DADE Behring, USA, and the DADE nephelometer Behring Analyzer II.
Diagnostic test: selected inflammatory markers - neopterin
Time frame: 3 years
neopterin [nmol/l] serum concentration was determined by using the Neopterin ELISA kit, DRG International, Inc., USA.
Diagnostic Test: selected inflammatory markers - interleukin 18 (IL-18)
Time frame: 3 years
interleukin 18 (IL-18) [pg/ml] concentration in the serum was determined by Colorimetric Sandwich ELISA, Quantikine Human IL-18 R\&D Inc., USA.
Diagnostic test: selected parameters of oxidative stress - myeloperoxidase (MPO)
Time frame: 3 years
myeloperoxidase (MPO) [ng/ml] in the serum - was determined by the ELISA method using the Quantikine Human MPO test by R\&D Systems kit, Canada.
Diagnostic test: selected parameters of oxidative stress - methylglyoxal (MG)
Time frame: 3 years
methylglyoxal (MG) [µg/mg protein] concentration in the serum was assessed by competitive enzyme immunoassay (competitive ELISA) using MG kits from Cell Biolabs Inc, USA.
Diagnostic test: selected parameters of oxidative stress - carboxyethyle(lysine) (CEL) [µg/mg protein]
Time frame: 3 years
carboxyethyle(lysine) (CEL) [µg/mg protein] concentration in the serum was assessed by competitive enzyme immunoassay (competitive ELISA) using CEL kits from Cell Biolabs Inc, USA.
Diagnostic test: selected parameters of oxidative stress - carbamyl protein groups [µg/mg protein]
Time frame: 3 years
carbamyl protein groups [µg/mg protein] concentration in the serum were assessed by competitive enzyme immunoassay (competitive ELISA) using carbamyl protein groups kits from Cell Biolabs Inc, USA.
Diagnostic test: selected parameters of oxidative stress - soluble receptor for advanced glycation end products (sRAGE)
Time frame: 3 years
soluble receptor for advanced glycation end products (sRAGE) [µg/mg protein] concentration in the serum was tested with enzymatic immunoassay (Quantikine ELISA) using R\&D Systems sRAGE kit, Canada.
Non-invasive cardiological examinations (1) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - blood pressures
Time frame: 3 years
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded: * peripheral systolic blood pressure (sSBP) [mmHg]; * peripheral diastolic blood pressure (pDBP)[mm Hg]; * peripheral mean arterial pressure (pMAP) [mm Hg]; * peripheral end-systolic pressure (pESP) [mm Hg]; * central systolic blood pressure (cSBP) [mm Hg]; * central diastolic blood pressure (cDBP) [mm Hg]; * central mean arterial pressure (cMAP) [mm Hg]; * entral augmented pressure (cAP) [mm Hg]; * central mean pressure of diastole (cMPD) [mm Hg]; * central mean pressure of systole (cMPS)[mm Hg]; * central end-systolic pressure (cESP)[mm Hg]
Non-invasive cardiological examinations (2) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - heart rate (HR)
Time frame: 3 years
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded: - heart rate (HR) in beats per minute [bpm]
Non-invasive cardiological examinations (3) with the use of Portapres device (Finapres Medical Systems (FMS), the Netherlands), the SphygmoCor tonometer (AtCor Medical), the Colin blood pressure monitor (BMP)-7000 (Japan) - ejection duration (ED)
Time frame: 3 years
Blood pressure was measured using the Colin BPM 7000 on both arms (participants were seated). Next, a piezoelectric tonometer Colin BPM was placed over the radial artery for the acquisition of the radial arterial pressure waveform in a supine position. This signal was sent to the SphygmoCor and after averaging various parameters have been assessed and recorded: - ejection duration (ED) in milliseconds [msec]
Device: carotid intima-media thickness (IMT)
Time frame: 3 years
Carotid intima-media thickness (IMT) [mm] was measured by The Accuson CV 70 system (Siemens) with a 10 megahertz (Mhz) transducer. Two longitudinal projections were assessed (anterolateral and posterolateral). The distal 1 cm of the common carotid artery just proximal to the bulb was measured by means of a computer analysis system (Medical Imaging Applications, LLC).
Device: vessel stiffness assessments - reflection index (RI)
Time frame: 3 years
The following parameter of vessel stiffness was assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom): - reflection index (RI) in percentages [%].
Device: vessel stiffness assessments - vascular stiffness index (SI)
Time frame: 3 years
The following parameter of vessel stiffness was assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom): -vascular stiffness index (SI) [m/s].
Device: vessel stiffness assessments - peripheral (pPP) and central pulse pressure (cPP) [mm Hg]
Time frame: 3 years
The following parameters of vessel stiffness were assessed by Pulse Trace 2000 (Micro Medical Ltd., Rochester, Kent, United Kingdom): * peripheral pulse pressure (pPP) [mm Hg]; * central pulse pressure (cPP) [mm Hg]
Device: vessel stiffness assessments - peripheral pulse pressure/central pulse pressure (pPP/cPP) ratio
Time frame: 3 years
Peripheral pulse pressure/central pulse pressure (pPP/cPP) ratio was assessed by dividing peripheral pulse pressure (pPP) [mm Hg] by central pulse pressure (cPP) [mm Hg].
Cardiovascular (CV)-related death recording during 2-year follow-up
Time frame: 2 years for each person qualified for the study
During a 2-year follow-up from the enrollment to this study, CV-related fatal incidents history has been recorded for each subject separately. The primary endpoint was fatal acute myocardial infarction (AMI) or acute ischemic stroke or any unexpected or sudden death only if autopsy proved CV-related. If there was doubt about the cause of death or there was no contact with the patient during the two years from study enrollment, that patient was excluded and not considered further.
Diagnostic test: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: 3 years
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [fmol/ml] concentration in the serum was analyzed by enzyme immunoassay using the Nt-proBNP kit from Biomedica, Slovakia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 36231682Twardawa M, Formanowicz P, Formanowicz D. Chronic Kidney Disease as a Cardiovascular Disorder-Tonometry Data Analyses. Int J Environ Res Public Health. 2022 Sep 28;19(19):12339. doi: 10.3390/ijerph191912339.
- Derived from this study: PubMed 35204237Kasprzak L, Twardawa M, Formanowicz P, Formanowicz D. The Mutual Contribution of 3-NT, IL-18, Albumin, and Phosphate Foreshadows Death of Hemodialyzed Patients in a 2-Year Follow-Up. Antioxidants (Basel). 2022 Feb 11;11(2):355. doi: 10.3390/antiox11020355.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Formanowicz, MD, PhD principal investigator
Poznan University of Mediccal Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis of Artery and Inflammation, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic test: basic biochemical parameters: complete blood count - hemoglobin (HGB) (time frame: 3 years). The study lists 55 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214872, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.