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

Heart Failure,Congestive Clinical Trial

— CATSTAT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389386
• Other study ID #: 2181-147-01/06/M.S.-17-2
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: April 16, 2019

Study information

• Verified date: April 2019
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

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 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.

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 as well as parameters of LV and RV strain in the selected subset of patients.

Locations

Country	Name	City	State
Croatia	University Hospital of Split	Split	Split-Dalmatia County

Sponsors (2)

Lead Sponsor	Collaborator
Josko Bozic	University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months