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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03389386
• Date of registration: 19/12/2017
• Prospective Registration: Yes
• Primary sponsor: Josko Bozic
• Public title: Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure CATSTAT-HF
• Scientific title: Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
• Date of first enrolment: January 25, 2018
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03389386
• Study type: Observational

Countries of recruitment

Croatia

Contacts

• Name: Josko Bozic, MD, PhD
• Affiliation: Department of Pathophysiology, University of Split School of Medicine

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure,Congestive

Intervention(s)

Other: Standard-of-care treatment

Diagnostic Test: Blood withdrawal for laboratory analysis

Diagnostic Test: Transthoracic echocardiography (TTE)

Primary Outcome(s)

Catestatin levels in blood serum [Time Frame: 3 months]

Secondary Outcome(s)

Relationship of serum catestatin levels with the selected laboratory indices [Time Frame: 3 months]

Relationship of serum catestatin levels with the echocardiographic parameters of cardiac function [Time Frame: 3 months]

Secondary ID(s)

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

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Split, School of Medicine