Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure

NCT ID: NCT03389386

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2019-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure,Congestive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood withdrawal for laboratory analysis

Intervention Type DIAGNOSTIC_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 treatment

Intervention Type OTHER

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)

Intervention Type 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.

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.

Blood withdrawal for laboratory analysis

Intervention Type DIAGNOSTIC_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.

Transthoracic echocardiography (TTE)

Intervention Type 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.

Interventions

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Blood withdrawal for laboratory analysis

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.

Intervention Type DIAGNOSTIC_TEST

Standard-of-care treatment

Patients diagnosed with chronic heart failure will receive optimal standards of care in terms of pharmacologic management, according to their current clinical condition.

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Split, School of Medicine

OTHER

Sponsor Role collaborator

Josko Bozic

OTHER

Sponsor Role lead

Responsible Party

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Josko Bozic

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Josko Bozic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pathophysiology, University of Split School of Medicine

Locations

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University Hospital of Split

Split, Split-Dalmatia County, Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type DERIVED
PMID: 32681700 (View on PubMed)

Borovac 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.

Reference Type DERIVED
PMID: 32370248 (View on PubMed)

Borovac 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.

Reference Type DERIVED
PMID: 31366074 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2181-147-01/06/M.S.-17-2

Identifier Type: -

Identifier Source: org_study_id

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