Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of this study is to investigate the effect of melatonin on clinical outcome, quality of life, and cardiovascular function of the patients with heart failure, as well as its effect on their skeletal muscle mass and function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Collaborator: National Institute for Medical Research Development
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Systolic heart failure with ejection fraction < 40, either ischemic or dilated cardiomyopathy (DCM)

• Symptoms and medications of HF have been stable for at least three months

• NYHA class II-III

• Willing to participate in the study and providing informed consent

Exclusion Criteria:

• Chronic comorbidities: insulin dependent diabetes, renal failure (GFR < 30 mL/min per 1.73 m2), uncontrolled endocrine disease, end-stage liver disease, rheumatological disease, chronic obstructive pulmonary disease (class D according to GOLD classification), morbid obesity (BMI > 35)

• Acute ischemic heart event or revascularization procedure in the last month

• Regular supervised exercise or ingestion of muscle hypertrophy supplementations in the last three months

• Vegetarian diet or sever restriction of protein in the diet in the last three months

• Occurrence of melatonin related adverse effects