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Plasma Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure (CATSTAT-HF)

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ClinicalTrials.gov Identifier: NCT03389386
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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 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 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 plasma CST levels will reflect the degree of neurohormonal activation in HF, showing a significant relationship with the degree of disease severity (according to NYHA classification). The investigators expect that among participants with worst clinical phenotypes of HF, CST levels in plasma will be highest and will decrease as the disease severity decreases. Secondly, the investigators expect to observe the significant correlation between CST levels in plasma with the echocardiographic parameters of the ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of inflammation, NT-proBNP levels and basic hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed from all the participants enrolled in the study. Furthermore, according to the latest European Society of Cardiology (ESC) guidelines, participants with established congestive HF will be prospectively stratified in three categories in respect to their left ventricular ejection fraction (LVEF) - HFrEF, HFmrEF, HFpEF. All the examined echocardiographic and blood parameters 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 according to their LVEF value.


Condition or disease Intervention/treatment
Heart Failure,Congestive Diagnostic Test: Blood withdrawal for laboratory analysis Other: Standard-of-care treatment Diagnostic Test: Transthoracic echocardiography (TTE)

Study Design

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Plasma Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Congestive Heart Failure (NYHA I-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 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 clinical condition.

Diagnostic Test: 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: plasma catestatin levels, NT-proBNP levels, parameters of inflammation, standard biochemistry and complete blood count (CBC).

Other: 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.
Diagnostic Test: Transthoracic echocardiography (TTE)
Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function.
Healthy Control Group

N= 50

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.

Diagnostic Test: 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: plasma catestatin levels, NT-proBNP levels, parameters of inflammation, standard biochemistry and complete blood count (CBC).

Diagnostic Test: Transthoracic echocardiography (TTE)
Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function.


Outcome Measures

Primary Outcome Measures :
  1. Catestatin levels in plasma [ Time Frame: 3 months ]
    The goal is to determine and compare plasma 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.


Secondary Outcome Measures :
  1. Relationship of plasma catestatin levels with the echocardiographic parameters of cardiac function [ Time Frame: 3 months ]
    The potential relationship of catestatin plasma levels with established parameters of systolic and diastolic cardiac function, as assessed by transthoracic echocardiography among patients with congestive heart failure will be examined.

  2. Relationship of plasma catestatin levels with the selected laboratory indices [ Time Frame: 3 months ]
    The potential relationship of catestatin plasma levels with the NT-proBNP, inflammatory biomarkers and standard hematologic/biochemical indices will be examined.


Biospecimen Retention:   Samples With DNA
Full blood obtained from the antecubital vein.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients in the Congestive Heart Failure group will be consecutively enrolled from the sample of patients with congestive heart failure that are being regularly treated and/or monitored through Division of Cardiology, Department of Internal Medicine, University Hospital of Split and that meet eligibility criteria.

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.

Criteria

Inclusion Criteria:

  • Healthy adult men and women, 35-80 years of age
  • Patients with clinically documented diagnosis of congestive heart failure (CHF) according to New York Heart Association (NYHA) functional classification (I-IV)

Exclusion Criteria:

  • Age criteria

    • Persons below legal age (<18 years)
    • Adults younger than 35 years of age
    • Adults older than 80 years of age
  • Participants with following conditions

    • Diabetes mellitus type I
    • Active malignant disease and/or active infectious disease
    • Significant systemic autoimmune disease
    • 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
    • Hemorrhagic diathesis or significant coagulopathy
    • Positive history of acute coronary syndrome or stroke within 3 months prior to enrollment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389386


Contacts
Contact: Josip A. Borovac + 385 92 172 1314 jborovac@mefst.hr

Locations
Croatia
University Hospital of Split Recruiting
Split, Split-Dalmatia County, Croatia, 21000
Contact: Josko Bozic    +385 98 388 601    josko.bozic@mefst.hr   
Contact: Josip A. Borovac    +385 92 172 1314    jborovac@mefst.hr   
Principal Investigator: Josko Bozic         
Principal Investigator: Josip A. Borovac         
Principal Investigator: Duska Glavas         
Sub-Investigator: Daniela Supe-Domic         
Sponsors and Collaborators
Josko Bozic
University of Split, School of Medicine
Investigators
Principal Investigator: Josko Bozic, MD, PhD Department of Pathophysiology, University of Split School of Medicine
  Study Documents (Full-Text)

Documents provided by Josko Bozic, University Hospital of Split:
Study Protocol  [PDF] December 26, 2017
Statistical Analysis Plan  [PDF] December 26, 2017

More Information

Responsible Party: Josko Bozic, Assistant Professor, University Hospital of Split
ClinicalTrials.gov Identifier: NCT03389386     History of Changes
Other Study ID Numbers: 2181-147-01/06/M.S.-17-2
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Josko Bozic, University Hospital of Split:
Congestive Heart Failure
Catestatin
Chromogranin A
Echocardiography
Biomarkers
Ventricular Dysfunction, Left
Comorbidity

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases