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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Melatonin tablets (10 mg)
Placebo tablets manufactured the same as melatonin tablets
Cardiac rehabilitation research center
Isfahan, Iran
RECRUITINGComposite clinical endpoint score
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)
Time frame: 6 months or earlier if patient was dropped out from the study
Adverse effects of melatonin
Adverse effects detected in the melatonin group compared with the placebo group
Time frame: Throughout the study up to 6 months
Change in appendicular lean mass (kg)
Measured by dual-energy x-ray absorptiometry
Time frame: Baseline and 6 months
Change in lean body mass (kg)
Measured by bioimpedance analysis
Time frame: Baseline and 3 months
Change in lean body mass (kg)
Measured by bioimpedance analysis
Time frame: Baseline and 6 months
Change in grip strength (kg)
Measured by a hydraulic dynamometer
Time frame: Baseline and 3 months
Change in grip strength (kg)
Measured by a hydraulic dynamometer
Time frame: Baseline and 6 months
Change in exercise capacity
Measured by 6 minute walk test
Time frame: Baseline and 3 months
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Change in exercise capacity
Measured by 6 minute walk test
Time frame: Baseline and 6 months
Change in Left ventricular ejection fraction (LVEF)
Measured by echocardiography using the Simpson method
Time frame: Baseline and 6 months
Change in left ventricular end-systolic volume (LVESV)
Measured by echocardiography using the Simpson method
Time frame: Baseline and 6 months
Change in endothelial dysfunction
Measured by flow-mediated vasodilation (FMD) method
Time frame: Baseline and 6 months
Change in mean systolic and diastolic blood pressures
Mean of two measurements, using an automated electronic oscillometric device
Time frame: Baseline and 3 months
Change in mean systolic and diastolic blood pressures
Mean of two measurements, using an automated electronic oscillometric device
Time frame: Baseline and 6 months