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Completed

NCT Number: NCT03389386

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

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.

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Key information

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood withdrawal for laboratory analysis

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

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)

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relationship of serum catestatin levels with the echocardiographic parameters of cardiac function

    Time frame: 3 months

    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.

  2. Relationship of serum catestatin levels with the selected laboratory indices

    Time frame: 3 months

    The potential relationship of catestatin serum levels with the NT-proBNP, inflammatory biomarkers and standard hematologic/biochemical indices will be examined.

Sponsors and collaborators

Lead sponsor

Josko Bozic

Other

Collaborators

  • University of Split, School of Medicine

Registry information

Acronym: CATSTAT-HF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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