CardiooncologyNCT03776331
Vascular Functions in Myeloma Patients During Anti-tumor Therapy
An observational study of Cardiooncology and Myeloma, run by University Hospital, Essen.
Trial summary
Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiooncology, Myeloma, Endothelial Dysfunction
- What is being tested?
- Flow mediated dilation
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2018to 28 Mar 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: The cohorts will be selected of the population of patients of the university clinic of Essen
Who may be able to join
- Age ≥ 18 years
- written consent
Who cannot join
- Severe pulmonary, valvular, or congenital heart disease with clinical dyspnoea symptoms
- Life expectancy less than 6 months
- Unstable angina pectoris or indication for coronary revascularization
- Valvular disease (aortic valve and mitral regurgitation greater than moderate, and aortic valve or mitral valve stenosis greater than moderate)
- Atrial fibrillation or flutter
- Chronic renal insufficiency (Cockcroft-Gault GFR <30 mL / min)
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- Severe cirrhosis (Child-Pugh B and C)
- Current or future indication for therapy with organic nitrates
- Leading non-cardiac cause of clinical dyspnea symptoms, such as high-grade obesity or lung disease in need of glucocorticoid therapy or oxygen therapy
- Other cause of clinical dyspnea symptoms, such as high-grade obesity or lung disease with need for glucocorticoid therapy or oxygen therapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characterization of Vascular Functions in Myeloma Patients Before and During Anti-tumor Therapy
Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years. Due to the advanced age, the myeloma patient collective has a high prevalence of pre-existing cardiovascular comorbidities. In addition, the primary disease process contributes to cardiovascular complications. With the beginning of anti-tumor therapy, an increased incidence of cardiovascular complications in myeloma patients can be determined. This includes hypertension, left ventricular dysfunction, heart failure and both arterial and venous thromboembolic events. The detailed mechanism by which proteasome inhibitors and immunomodulatory agents lead to increased cardiovascular events is not established at this time. Endothelial dysfunction, as a possible mechanism of cardiovascular toxicity, is difficult to assess. Flow-mediated dilation (FMD) is an noninvasive method to measure endothelial function by assessing the change in the vasodilatative reserve of the brachial artery. Several independent recent investigations implicate that vascular (endothelial) dysfunction precedes hypertension and heart failure. This has been related to a reduced level of metabolites of the l-arginine-nitric oxide (NO) signaling pathway.
Hypothesis:
Read more
- Anti-myeloma therapy exert vascular toxicity by limiting endothelial function. Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) decreases after myeloma therapy.
- Patients with multiple myeloma have a limited endothelial function compared to a healthy control group.
A total of 40 myeloma patients will be examined. Measurements will be taken at baseline, 1 month and 6 month after myeloma therapy. Patients should not have received chemotherapy for at least 3 months. Furthermore a healthy sex- and age-matched control group will be examined.
Read the detailed description
Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years, many continue to live for more than 10 years. Due to the advanced age, the myeloma patient collective has a high prevalence of pre-existing cardiovascular comorbidities. In addition, the primary disease process contributes to cardiovascular complications. With the beginning of anti-tumor therapy, an increased incidence of cardiovascular complications in myeloma patients can be determined. This includes hypertension, left ventricular dysfunction, heart failure and both arterial and venous thromboembolic events.
Proteasome inhibitors including bortezomib and carfilzomib, and immunomodulatory agents, e.g. lenalidomide, represent cornerstone therapies for multiple myeloma. The most common therapy choices are Bortezomib-based therapy (VCD, VC) and Carfilzomib-based therapy (KRD, KD). Induction therapy is given 4-6 cycles followed by autologous hematopoietic cell transplantation. Thereafter, many patients receive consolidation therapy. In patients not eligible for autologous hematopoietic cell transplantation, a prolonged course of initial chemotherapy is typically administered. The proteasome inhibitor Bortezomib is used predominately in the front line setting, while second-generation carfilzomib is used in relapsed/refractory disease.
Despite their efficacy, increased rates of cardiovascular complications occur in patients exposed to these particular therapies. Higher incidences of cardiac adverse events including hypertension, arrhythmia, heart failure, ischemic heart disease and cardiomyopathy has been reported in patients receiving carfilzomib and bortezomib. Immunomodulatory agents are known to increase the risk of venous thromboembolic disease particularly when combined with dexamethasone or other chemotherapy. Furthermore, increased incidence of myocardial infarction (MI) and cerebrovascular events has been demonstrated in patients treated with lenalidomide. The mechanism of PI- and IMiD-associated cardiotoxicity is not fully elucidated. PIs inhibit proteasome activity, leading to the accumulation of abnormal proteins which in turn activates apoptotic pathways in myeloma cells. IMiDs bind cereblon, a component of the E3 ubiquitin ligase which promotes proteasome-mediated degradation of the transcription factors, IKZF1 and IKZF. It is unclear if the protein degradation properties of these drugs contribute to cardiotoxicity, although clinical features of the toxicity suggest endothelial cell injury and dysfunction. It is possible that CV events may be augmented when these two classes of medications are co-administered and further enhanced by the additional endothelial stress conferred by steroids. The detailed mechanism by which proteasome inhibitors and immunomodulatory agents lead to increased cardiovascular events is not established at this time.
Endothelial dysfunction, as a possible mechanism of cardiovascular toxicity, is difficult to assess. Flow-mediated dilation (FMD) is an noninvasive method to measure endothelial function by assessing the change in the vasodilatative reserve of the brachial artery. Several independent recent investigations implicate that vascular (endothelial) dysfunction precedes hypertension and heart failure. This has been related to a reduced level of metabolites of the l-arginine-nitric oxide (NO) signaling pathway.
Hypothesis:
- Anti-myeloma therapy exert vascular toxicity by limiting endothelial function. Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) decreases after myeloma therapy.
- Patients with multiple myeloma have a limited endothelial function compared to a healthy control group.
Study design:
A total of 40 myeloma patients will be examined. Measurements will be taken at baseline, 1 month 6 month after myeloma therapy. Patients should not have received chemotherapy for at least 3 months. Furthermore a healthy sex- and age-matched control group will be examined.
Primary endpoint:
- Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD), between baseline and 1 month data
Secondary endpoints:
- Endothelial function, assessed by the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) between baseline data in myeloma patients and control group
- Change of left ventricular pump function (3D-EF, global longitudinal strain)
- Alteration of echocardiographic parameters of diastolic dysfunction
- Change in dyspnea symptoms (NYHA Classification)
- Modification of cardiac biomarkers (NT-pro BNP, Troponin)
- Change of circulating NO-Pool
- Change in metabolomics (Biobank)
- Change in arterial stiffness and augmentation index
- Change of quality of life rated according to Medical Outcomes Short-Form Survey, SF-36, Minnesota Living With Heart Failure Questionnaire
- Change in blood pressure
- Conditions
- Cardiooncology, Myeloma, Endothelial Dysfunction
- Being tested
- Flow mediated dilation
- Keywords
- Myeloma, Flow mediated dilation, Endothelial Dysfunction, Proteasome inhibitors
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow mediated dilationDiagnostic test
Measurement of the change in the vasodilatative reserve of the brachial artery
| Study group | Role | What they receive |
|---|---|---|
| Myeloma Patients | Not described Receives: Diagnostic Test: Flow mediated dilation | |
| Controll group | Not described Receives: Diagnostic Test: Flow mediated dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Measured: between baseline and 1 month data
Secondary outcomes (21)
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Measured: between baseline and 6 month data
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Measured: between 1 and 6 month data
Change of endothelial function, assessed by the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) between baseline data in myeloma patients and control group
Measured: baseline data
Change of left ventricular pump function (3D-EF)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of left ventricular pump function (global longitudinal strain)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Alteration of grade of diastolic dysfunction
Assesed by E, E/A, E/e', IVRT, DT, e', e'/a', TEI index, sPAP, according to ASE/EACVI GUIDELINES AND STANDARDS, Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging, Sherif et al, 2016, J Am Soc Echocardiogr, 2016
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in dyspnea symptoms (NYHA Classification)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in concentration of Troponin
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in concentration of NT-pro BNP
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in circulating arginine-nitric oxide (NO) metabolites
Levels of arginine, citrulline, ornithine, asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), and N-monomethylarginine (MMA)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating arginine
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in leves of circulating citrulline
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating ornithine
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating asymmetric dimethylarginine (ADMA)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating symmetric dimethylarginine (SDMA)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating N-monomethylarginine (MMA)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in pulse wave velocity as a parameter of arterial stiffness
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in augmentation index
Augmentation index (AIx), the pressure difference between the shoulder on the pressure wave and systolic pressure expressed as a ratio of pulse pressure is widely used as a proxy of wave reflection
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of quality of life rated according to Minnesota Living With Heart Failure Questionnaire
The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of quality of life rated according to Medical Outcomes Short-Form Survey
The SF-36 consists of 36 questions and is a general health questionnaire that provides information about the health status of the patient through 8 different dimensions. He makes statements about:
General Health Perception, Physical Health, Restricted physical role function, Physical pain, Vitality, Mental Healt, Restricted emotional role function, Social functioning. For the evaluation of the SF-36 questionnaire v1.0 you first recode all answers in predefined points using a recoding table. Then you calculate the average score of all questions of the respective health dimension, e.g. physical health, so you have 8 average points for the 8 dimensions. These 8 scores now describe the health status of the patient in their respective dimensions, which can then be assessed using comparison charts.
The possible score ranges from 0 to 100 points. 0 points represent the greatest possible restriction of health, while 100 points represent the absence of health restrictions.
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in blood pressure (systolic, diastolic and MAD)
Measured: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start28 Dec 2018 (estimated)
- Primary completion28 Dec 2019 (estimated)
- Study completion28 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiooncologyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
- Investigators
- Matthias Totzeck, Principal investigator, Universitätsklinikum Essen AOeR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776331
- Sponsor's protocol ID
- Vascular-Myelom
- Status last verified
- Dec 2018
- First submitted
- 10 Nov 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Vascular Functions in Myeloma Patients Before and During Anti-tumor Therapy
- ClinicalTrials.gov ID
- NCT03776331
- Acronym / sponsor ID
- Vascular-Myelom
- Conditions
- Cardiooncology, Myeloma, Endothelial Dysfunction
- Keywords
- Myeloma, Flow mediated dilation, Endothelial Dysfunction, Proteasome inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 28 Dec 2018 (estimated)
- Primary completion
- 28 Dec 2019 (estimated)
- Study completion
- 28 Mar 2020 (estimated)
- First posted
- 14 Dec 2018 (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.
Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years. Due to the advanced age, the myeloma patient collective has a high prevalence of pre-existing cardiovascular comorbidities. In addition, the primary disease process contributes to cardiovascular complications. With the beginning of anti-tumor therapy, an increased incidence of cardiovascular complications in myeloma patients can be determined. This includes hypertension, left ventricular dysfunction, heart failure and both arterial and venous thromboembolic events. The detailed mechanism by which proteasome inhibitors and immunomodulatory agents lead to increased cardiovascular events is not established at this time. Endothelial dysfunction, as a possible mechanism of cardiovascular toxicity, is difficult to assess. Flow-mediated dilation (FMD) is an noninvasive method to measure endothelial function by assessing the change in the vasodilatative reserve of the brachial artery. Several independent recent investigations implicate that vascular (endothelial) dysfunction precedes hypertension and heart failure. This has been related to a reduced level of metabolites of the l-arginine-nitric oxide (NO) signaling pathway.
Hypothesis:
- Anti-myeloma therapy exert vascular toxicity by limiting endothelial function. Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) decreases after myeloma therapy.
- Patients with multiple myeloma have a limited endothelial function compared to a healthy control group.
A total of 40 myeloma patients will be examined. Measurements will be taken at baseline, 1 month and 6 month after myeloma therapy. Patients should not have received chemotherapy for at least 3 months. Furthermore a healthy sex- and age-matched control group will be examined.
Detailed description
Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years, many continue to live for more than 10 years. Due to the advanced age, the myeloma patient collective has a high prevalence of pre-existing cardiovascular comorbidities. In addition, the primary disease process contributes to cardiovascular complications. With the beginning of anti-tumor therapy, an increased incidence of cardiovascular complications in myeloma patients can be determined. This includes hypertension, left ventricular dysfunction, heart failure and both arterial and venous thromboembolic events.
Proteasome inhibitors including bortezomib and carfilzomib, and immunomodulatory agents, e.g. lenalidomide, represent cornerstone therapies for multiple myeloma. The most common therapy choices are Bortezomib-based therapy (VCD, VC) and Carfilzomib-based therapy (KRD, KD). Induction therapy is given 4-6 cycles followed by autologous hematopoietic cell transplantation. Thereafter, many patients receive consolidation therapy. In patients not eligible for autologous hematopoietic cell transplantation, a prolonged course of initial chemotherapy is typically administered. The proteasome inhibitor Bortezomib is used predominately in the front line setting, while second-generation carfilzomib is used in relapsed/refractory disease.
Despite their efficacy, increased rates of cardiovascular complications occur in patients exposed to these particular therapies. Higher incidences of cardiac adverse events including hypertension, arrhythmia, heart failure, ischemic heart disease and cardiomyopathy has been reported in patients receiving carfilzomib and bortezomib. Immunomodulatory agents are known to increase the risk of venous thromboembolic disease particularly when combined with dexamethasone or other chemotherapy. Furthermore, increased incidence of myocardial infarction (MI) and cerebrovascular events has been demonstrated in patients treated with lenalidomide. The mechanism of PI- and IMiD-associated cardiotoxicity is not fully elucidated. PIs inhibit proteasome activity, leading to the accumulation of abnormal proteins which in turn activates apoptotic pathways in myeloma cells. IMiDs bind cereblon, a component of the E3 ubiquitin ligase which promotes proteasome-mediated degradation of the transcription factors, IKZF1 and IKZF. It is unclear if the protein degradation properties of these drugs contribute to cardiotoxicity, although clinical features of the toxicity suggest endothelial cell injury and dysfunction. It is possible that CV events may be augmented when these two classes of medications are co-administered and further enhanced by the additional endothelial stress conferred by steroids. The detailed mechanism by which proteasome inhibitors and immunomodulatory agents lead to increased cardiovascular events is not established at this time.
Endothelial dysfunction, as a possible mechanism of cardiovascular toxicity, is difficult to assess. Flow-mediated dilation (FMD) is an noninvasive method to measure endothelial function by assessing the change in the vasodilatative reserve of the brachial artery. Several independent recent investigations implicate that vascular (endothelial) dysfunction precedes hypertension and heart failure. This has been related to a reduced level of metabolites of the l-arginine-nitric oxide (NO) signaling pathway.
Hypothesis:
- Anti-myeloma therapy exert vascular toxicity by limiting endothelial function. Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) decreases after myeloma therapy.
- Patients with multiple myeloma have a limited endothelial function compared to a healthy control group.
Study design:
A total of 40 myeloma patients will be examined. Measurements will be taken at baseline, 1 month 6 month after myeloma therapy. Patients should not have received chemotherapy for at least 3 months. Furthermore a healthy sex- and age-matched control group will be examined.
Primary endpoint:
- Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD), between baseline and 1 month data
Secondary endpoints:
- Endothelial function, assessed by the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) between baseline data in myeloma patients and control group
- Change of left ventricular pump function (3D-EF, global longitudinal strain)
- Alteration of echocardiographic parameters of diastolic dysfunction
- Change in dyspnea symptoms (NYHA Classification)
- Modification of cardiac biomarkers (NT-pro BNP, Troponin)
- Change of circulating NO-Pool
- Change in metabolomics (Biobank)
- Change in arterial stiffness and augmentation index
- Change of quality of life rated according to Medical Outcomes Short-Form Survey, SF-36, Minnesota Living With Heart Failure Questionnaire
- Change in blood pressure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myeloma Patients | – | Diagnostic Test: Flow mediated dilation |
| Controll group | – | Diagnostic Test: Flow mediated dilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohorts will be selected of the population of patients of the university clinic of Essen
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- written consent
Key exclusion criteria (10 listed)
- Severe pulmonary, valvular, or congenital heart disease with clinical dyspnoea symptoms
- Life expectancy less than 6 months
- Unstable angina pectoris or indication for coronary revascularization
- Valvular disease (aortic valve and mitral regurgitation greater than moderate, and aortic valve or mitral valve stenosis greater than moderate)
- Atrial fibrillation or flutter
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 |
|---|---|---|
| Flow mediated dilationMeasurement of the change in the vasodilatative reserve of the brachial artery | Diagnostic test | Controll group, Myeloma Patients |
Primary outcome
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Time frame: between baseline and 1 month data
21 secondary outcomes
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Time frame: between baseline and 6 month data
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Time frame: between 1 and 6 month data
Change of endothelial function, assessed by the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) between baseline data in myeloma patients and control group
Time frame: baseline data
Change of left ventricular pump function (3D-EF)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of left ventricular pump function (global longitudinal strain)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Alteration of grade of diastolic dysfunction
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in dyspnea symptoms (NYHA Classification)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in concentration of Troponin
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in concentration of NT-pro BNP
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in circulating arginine-nitric oxide (NO) metabolites
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating arginine
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in leves of circulating citrulline
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating ornithine
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating asymmetric dimethylarginine (ADMA)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating symmetric dimethylarginine (SDMA)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in levels of circulating N-monomethylarginine (MMA)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in pulse wave velocity as a parameter of arterial stiffness
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in augmentation index
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of quality of life rated according to Minnesota Living With Heart Failure Questionnaire
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change of quality of life rated according to Medical Outcomes Short-Form Survey
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Change in blood pressure (systolic, diastolic and MAD)
Time frame: between baseline and 1 month data/baseline and 6 month data/1 and 6 month data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Yes
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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.
Matthias Totzeck principal investigator
Universitätsklinikum Essen AOeR
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiooncology and Myeloma, run by University Hospital, Essen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Totzeck (004920172384805, matthias.totzeck@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) (time frame: between baseline and 1 month data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.