Heart Failure，CongestiveCATSTAT-HFNCT03389386
Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
An observational study of Heart Failure，Congestive, run by Josko Bozic at 1 site in Croatia.
Trial summary
The congestive heart failure (HF) is a condition associated with substantial morbidity, mortality, and high healthcare expenditures. From the pathophysiological standpoint, several mechanisms contribute to the progression and dysfunction of the failing heart such as an increased hemodynamic overload, impaired myocyte… Read more about this study
- Who is it for?
- Ages 35 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Blood withdrawal for laboratory analysis, Standard-of-care treatment and Transthoracic echocardiography (TTE)
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 25 Jan 2018to 16 Apr 2019
- 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 35 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the Congestive Heart Failure group will be consecutively enrolled from the pool of patients that will present with signs and symptoms of heart failure at Internal Medicine Emergency Department (ED) of the University Hospital of Split and will be subsequently admitted and hospitalized with working diagnosis of decompensated heart failure (I50.0). Patients that meet eligibility criteria and do not fulfill any of the excluding criteria will be further included in the study. Participants in the Healthy Control group will be enrolled from the sample of healthy residents of Split or nearby communities that meet the eligibility criteria for the study inclusion.
Who may be able to join
- Healthy adult men and women, 35-90 years of age
- Patients with clinically documented diagnosis of congestive heart failure (CHF) according to New York Heart Association (NYHA) functional classification (II-IV)
Who cannot join
- Age criteria:
- Persons below legal age (<18 years)
- Adults younger than 35 years of age
- Adults older than 90 years of age
- Participants with following conditions:
- Diabetes mellitus type I
Show all 18Show fewer
- Documented or newly-established severe valvular or pericardial disease
- Infiltrative or hypertrophic cardiomyopathy
- Primary pulmonary disease or cor pulmonale
- Active malignant disease and/or active infectious disease
- Significant systemic autoimmune disease
- A positive history of excessive alcohol, drug, narcotics, and sedative consumption
- Significant psychiatric or neurologic condition
- Immunocompromised patients or patients that are under immunosuppressive treatment
- Significant liver or renal insufficiency (primary renal or hepatic disease)
- Hemorrhagic diathesis or significant coagulopathy
- Positive recent history of cancer chemotherapeutic drug use
- A positive history of acute coronary syndrome or stroke within 3 months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital of Split
Split, Split-Dalmatia County, 21000
About this study
The congestive heart failure (HF) is a condition associated with substantial morbidity, mortality, and high healthcare expenditures. From the pathophysiological standpoint, several mechanisms contribute to the progression and dysfunction of the failing heart such as an increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic activity, deficient or increased production of extracellular matrix, genetic predilections and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in the situation of impaired cardiac output.
Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A (CgA) that is involved in the regulation of cardiac function and arterial blood pressure. The role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this study is that the observed serum CST levels will reflect the degree of neurohormonal activation in HF, showing a significant relationship with the degree of disease severity as measured by relevant functional classifications (such as NYHA class and/or similar). Secondly, investigators expect to detect correlation of catestatin serum levels with the established risk stratification scores in HF and with the echocardiographic parameters of the ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of inflammation, NT-proBNP, hs-cTnI, renal function parameters, and basic hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed for all study participants.
Read more
Furthermore, according to the latest European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic HF, participants with established congestive HF and the whole spectrum of left ventricular ejection fractions ranging from <40% to ≥50% will be included in the study.
Finally, all echocardiographic and laboratory parameters obtained from peripheral blood will be recorded and compared with respective healthy and matched control participants while participants diagnosed with HF will additionally be analyzed for potential differences between subgroups of interest.
- Conditions
- Heart Failure，Congestive
- Being tested
- Blood withdrawal for laboratory analysis, Standard-of-care treatment, Transthoracic echocardiography (TTE)
- Keywords
- Congestive Heart Failure, Catestatin, Chromogranin A, Echocardiography, Biomarkers, Ventricular Dysfunction, Left, Comorbidity
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawal for laboratory analysisDiagnostic test
Participants in this study will have their peripheral blood sampled from the cubital vein and the total volume withdrawn for the purposes of this study will be no more than 22 mL per person.
Parameters of interest in the laboratory analysis will include serum catestatin levels, NT-proBNP levels, hs-cTnI, parameters of inflammation and renal function as well as standard biochemistry and complete blood count (CBC) panels.
Standard-of-care treatmentOther
Patients diagnosed with chronic heart failure will receive optimal standards of care in terms of pharmacologic management, according to their current clinical condition.
Transthoracic echocardiography (TTE)Diagnostic test
Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function as well as parameters of LV and RV strain in the selected subset of patients.
| Study group | Role | What they receive |
|---|---|---|
| Congestive Heart Failure (NYHA II-IV) | N=90
Patients with a clinically documented diagnosis of congestive heart failure (CHF), as assessed per New York Heart Association (NYHA) functional classification will be prospectively and consecutively enrolled in this group. Patients will be of both sexes, enrolled in 1:1 ratio.
All subjects in this group will undergo blood withdrawal for laboratory analysis, transthoracic echocardiography (TTE) examination and will be treated with the Standard-of-care treatment according to their current clinical condition at admission. Receives: Diagnostic Test: Blood withdrawal for laboratory analysis; Other: Standard-of-care treatment; Diagnostic Test: Transthoracic echocardiography (TTE) | |
| Healthy Control Group | N=30
Healthy volunteers (both sexes, enrolled in 1:1 ratio) with a negative history of cardiovascular diseases will be enrolled in this group that will serve as a study control.
All subjects in this group will undergo blood withdrawal for laboratory analysis and transthoracic echocardiography (TTE) examination. Receives: Diagnostic Test: Blood withdrawal for laboratory analysis; Diagnostic Test: Transthoracic echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catestatin levels in blood serum
The goal is to determine and compare serum catestatin levels in patients with congestive heart failure, stratified by the left ventricular ejection fraction (LVEF) in three groups: reduced, mid-range, and preserved ejection fraction (HFrEF, HFmrEF, HFpEF). Furthermore, catestatin plasma levels will be compared between patients with congestive heart failure and healthy volunteers.
Measured: 3 months
Secondary outcomes (2)
Relationship of serum catestatin levels with the echocardiographic parameters of cardiac function
The potential relationship of catestatin serum levels with established parameters of systolic and diastolic cardiac function, as assessed by transthoracic echocardiography among patients with congestive heart failure will be examined.
Measured: 3 months
Relationship of serum catestatin levels with the selected laboratory indices
The potential relationship of catestatin serum levels with the NT-proBNP, inflammatory biomarkers and standard hematologic/biochemical indices will be examined.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start25 Jan 2018
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josko Bozic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Split, School of Medicine
- Responsible party
- Sponsor-investigator, Josko Bozic, University Hospital of Split
- Investigators
- Josko Bozic, MD, PhD, Principal investigator, Department of Pathophysiology, University of Split School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389386
- Sponsor's protocol ID
- 2181-147-01/06/M.S.-17-2
- Acronym
- CATSTAT-HF
- Status last verified
- Apr 2019
- First submitted
- 19 Dec 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, Stanisic L, D'Amario D, Kwok CS, Bozic J. Circulating sST2 and catestatin levels in patients with acute worsening of heart failure: a report from the CATSTAT-HF study. ESC Heart Fail. 2020 Oct;7(5):2818-2828. doi: 10.1002/ehf2.12882. Epub 2020 Jul 18.
PubMed 32681700Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, Stanisic L, D'Amario D, Duplancic D, Bozic J. Right Ventricular Free Wall Strain and Congestive Hepatopathy in Patients with Acute Worsening of Chronic Heart Failure: A CATSTAT-HF Echo Substudy. J Clin Med. 2020 May 2;9(5):1317. doi: 10.3390/jcm9051317.
PubMed 32370248Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, D'Amario D, Bozic J. Catestatin in Acutely Decompensated Heart Failure Patients: Insights from the CATSTAT-HF Study. J Clin Med. 2019 Jul 30;8(8):1132. doi: 10.3390/jcm8081132.
PubMed 31366074
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT03389386
- Acronym / sponsor ID
- CATSTAT-HF / 2181-147-01/06/M.S.-17-2
- Conditions
- Heart Failure，Congestive
- Keywords
- Congestive Heart Failure, Catestatin, Chromogranin A, Echocardiography, Biomarkers, Ventricular Dysfunction, Left, Comorbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Josko BozicUniversity, hospital or other
- Collaborators
- University of Split, School of Medicine
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 3 Jan 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.
The congestive heart failure (HF) is a condition associated with substantial morbidity, mortality, and high healthcare expenditures. From the pathophysiological standpoint, several mechanisms contribute to the progression and dysfunction of the failing heart such as an increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic activity, deficient or increased production of extracellular matrix, genetic predilections and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in the situation of impaired cardiac output.
Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A (CgA) that is involved in the regulation of cardiac function and arterial blood pressure. The role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this study is that the observed serum CST levels will reflect the degree of neurohormonal activation in HF, showing a significant relationship with the degree of disease severity as measured by relevant functional classifications (such as NYHA class and/or similar). Secondly, investigators expect to detect correlation of catestatin serum levels with the established risk stratification scores in HF and with the echocardiographic parameters of the ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of inflammation, NT-proBNP, hs-cTnI, renal function parameters, and basic hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed for all study participants.
Furthermore, according to the latest European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic HF, participants with established congestive HF and the whole spectrum of left ventricular ejection fractions ranging from <40% to ≥50% will be included in the study.
Finally, all echocardiographic and laboratory parameters obtained from peripheral blood will be recorded and compared with respective healthy and matched control participants while participants diagnosed with HF will additionally be analyzed for potential differences between subgroups of interest.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congestive Heart Failure (NYHA II-IV) | – | Diagnostic Test: Blood withdrawal for laboratory analysis, Other: Standard-of-care treatment, Diagnostic Test: Transthoracic echocardiography (TTE)N=90 Patients with a clinically documented diagnosis of congestive heart failure (CHF), as assessed per New York Heart Association (NYHA) functional classification will be prospectively and consecutively enrolled in this group. Patients will be of both sexes, enrolled in 1:1 ratio. All subjects in this group will undergo blood withdrawal for laboratory analysis, transthoracic echocardiography (TTE) examination and will be treated with the Standard-of-care treatment according to their current clinical condition at admission. |
| Healthy Control Group | – | Diagnostic Test: Blood withdrawal for laboratory analysis, Diagnostic Test: Transthoracic echocardiography (TTE)N=30 Healthy volunteers (both sexes, enrolled in 1:1 ratio) with a negative history of cardiovascular diseases will be enrolled in this group that will serve as a study control. All subjects in this group will undergo blood withdrawal for laboratory analysis and transthoracic echocardiography (TTE) examination. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Congestive Heart Failure group will be consecutively enrolled from the pool of patients that will present with signs and symptoms of heart failure at Internal Medicine Emergency Department (ED) of the University Hospital of Split and will be subsequently admitted and hospitalized with working diagnosis of decompensated heart failure (I50.0). Patients that meet eligibility criteria and do not fulfill any of the excluding criteria will be further included in the study. Participants in the Healthy Control group will be enrolled from the sample of healthy residents of Split or nearby communities that meet the eligibility criteria for the study inclusion.
Key inclusion criteria (2 listed)
- Healthy adult men and women, 35-90 years of age
- Patients with clinically documented diagnosis of congestive heart failure (CHF) according to New York Heart Association (NYHA) functional classification (II-IV)
Key exclusion criteria (18 listed)
- Age criteria:
- Participants with following conditions:
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 |
|---|---|---|
| Blood withdrawal for laboratory analysisParticipants in this study will have their peripheral blood sampled from the cubital vein and the total volume withdrawn for the purposes of this study will be no more than 22 mL per person. Parameters of interest in the laboratory analysis will include serum catestatin levels, NT-proBNP levels, hs-cTnI, parameters of inflammation and renal function as well as standard biochemistry and complete blood count (CBC) panels. | Diagnostic test | Congestive Heart Failure (NYHA II-IV), Healthy Control Group |
| Standard-of-care treatmentPatients diagnosed with chronic heart failure will receive optimal standards of care in terms of pharmacologic management, according to their current clinical condition. | Other | Congestive Heart Failure (NYHA II-IV) |
| Transthoracic echocardiography (TTE)Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function as well as parameters of LV and RV strain in the selected subset of patients. | Diagnostic test | Congestive Heart Failure (NYHA II-IV), Healthy Control Group |
Primary outcome
Catestatin levels in blood serum
Time frame: 3 months
The goal is to determine and compare serum catestatin levels in patients with congestive heart failure, stratified by the left ventricular ejection fraction (LVEF) in three groups: reduced, mid-range, and preserved ejection fraction (HFrEF, HFmrEF, HFpEF). Furthermore, catestatin plasma levels will be compared between patients with congestive heart failure and healthy volunteers.
2 secondary outcomes
Relationship of serum catestatin levels with the echocardiographic parameters of cardiac function
Time frame: 3 months
Relationship of serum catestatin levels with the selected laboratory indices
Time frame: 3 months
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 17 Apr 2019.
- Derived from this study: PubMed 32681700Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, Stanisic L, D'Amario D, Kwok CS, Bozic J. Circulating sST2 and catestatin levels in patients with acute worsening of heart failure: a report from the CATSTAT-HF study. ESC Heart Fail. 2020 Oct;7(5):2818-2828. doi: 10.1002/ehf2.12882. Epub 2020 Jul 18.
- Derived from this study: PubMed 32370248Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, Stanisic L, D'Amario D, Duplancic D, Bozic J. Right Ventricular Free Wall Strain and Congestive Hepatopathy in Patients with Acute Worsening of Chronic Heart Failure: A CATSTAT-HF Echo Substudy. J Clin Med. 2020 May 2;9(5):1317. doi: 10.3390/jcm9051317.
- Derived from this study: PubMed 31366074Borovac JA, Glavas D, Susilovic Grabovac Z, Supe Domic D, D'Amario D, Bozic J. Catestatin in Acutely Decompensated Heart Failure Patients: Insights from the CATSTAT-HF Study. J Clin Med. 2019 Jul 30;8(8):1132. doi: 10.3390/jcm8081132.
- Individual participant dataSharing planned: No
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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.
Josko Bozic, MD, PhD principal investigator
Department of Pathophysiology, University of Split School of Medicine
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 Heart Failure，Congestive, run by Josko Bozic at 1 site in Croatia.
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 18 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 Croatia. 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?
Catestatin levels in blood serum (time frame: 3 months). 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 NCT03389386, which also lists 3 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 17 Apr 2019.