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

Josko Bozic

Status: Completed

Conditions: Heart Failure，Congestive

Treatments: Other: Standard-of-care treatment; Diagnostic Test: Blood withdrawal for laboratory analysis; Diagnostic Test: Transthoracic echocardiography (TTE)

Study type: Observational

Funder types: Other

Identifiers

NCT03389386

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

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 35 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Congestive Heart Failure (NYHA II-IV)

Description:

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.

Treatment:

Diagnostic Test: Blood withdrawal for laboratory analysis

Diagnostic Test: Transthoracic echocardiography (TTE)

Other: Standard-of-care treatment

Healthy Control Group

Description:

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.

Treatment:

Diagnostic Test: Blood withdrawal for laboratory analysis

Diagnostic Test: Transthoracic echocardiography (TTE)