Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03894683
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief 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.
- Detailed Description
People with heart failure (HF) suffer from various comorbidities and complications which their management is as important as treatment of HF per se. An important complication of the HF is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. Prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with HF. Melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. Recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. Experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. In this study the effect of melatonin on clinical outcome and quality of life of the patients with HF and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Melatonin Melatonin 10 mg Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months Placebo Placebo Oral Tablet Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.
- Primary Outcome Measures
Name Time Method Composite clinical endpoint score 6 months or earlier if patient was dropped out from the study A score with the following components: all-cause mortality, hospitalization for heart failure during the study, and change in quality of life by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
- Secondary Outcome Measures
Name Time Method Adverse effects of melatonin Throughout the study up to 6 months Adverse effects detected in the melatonin group compared with the placebo group
Change in lean body mass (kg) Baseline and 6 months Measured by bioimpedance analysis
Change in grip strength (kg) Baseline and 6 months Measured by a hydraulic dynamometer
Change in exercise capacity Baseline and 6 months Measured by 6 minute walk test
Change in left ventricular end-systolic volume (LVESV) Baseline and 6 months Measured by echocardiography using the Simpson method
Change in endothelial dysfunction Baseline and 6 months Measured by flow-mediated vasodilation (FMD) method
Change in appendicular lean mass (kg) Baseline and 6 months Measured by dual-energy x-ray absorptiometry
Change in Left ventricular ejection fraction (LVEF) Baseline and 6 months Measured by echocardiography using the Simpson method
Change in mean systolic and diastolic blood pressures Baseline and 6 months Mean of two measurements, using an automated electronic oscillometric device
Trial Locations
- Locations (1)
Cardiac rehabilitation research center
🇮🇷Isfahan, Iran, Islamic Republic of