Clinical trial NCT03894683: Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure
Official title: Effect of Melatonin on Cardiovascular and Muscle Function in Patients With Heart Failure: a Double Blinded Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Heart failure
Melatonin
Muscle wasting
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research Development
First posted: 2019-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite clinical endpoint score
timeFrame: 6 months or earlier if patient was dropped out from the study
Secondary outcomes:
measure: Adverse effects of melatonin
timeFrame: Throughout the study up to 6 months
measure: Change in appendicular lean mass (kg)
timeFrame: Baseline and 6 months
measure: Change in lean body mass (kg)
timeFrame: Baseline and 3 months
measure: Change in lean body mass (kg)
timeFrame: Baseline and 6 months
measure: Change in grip strength (kg)
timeFrame: Baseline and 3 months
measure: Change in grip strength (kg)
timeFrame: Baseline and 6 months
measure: Change in exercise capacity
timeFrame: Baseline and 3 months
measure: Change in exercise capacity
timeFrame: Baseline and 6 months
measure: Change in Left ventricular ejection fraction (LVEF)
timeFrame: Baseline and 6 months
measure: Change in left ventricular end-systolic volume (LVESV)
timeFrame: Baseline and 6 months
measure: Change in endothelial dysfunction
timeFrame: Baseline and 6 months
measure: Change in mean systolic and diastolic blood pressures
timeFrame: Baseline and 3 months
measure: Change in mean systolic and diastolic blood pressures
timeFrame: Baseline and 6 months
Other outcomes:
measure: Change in fasting blood glucose level (mg/dl)
timeFrame: Baseline and 6 months
measure: Change in serum lipid levels (mg/dl)
timeFrame: Baseline and 6 months
measure: Change in serum insulin, and IGF-1 levels
timeFrame: Baseline and 6 months
measure: Change in level of serum inflammatory biomarkers
timeFrame: Baseline and 6 months
measure: Change in level of serum oxidative stress biomarkers
timeFrame: Baseline and 6 months
measure: Changes in psychological status of the patients
timeFrame: Baseline and 6 months
measure: Changes in sleep quality of the patients
timeFrame: Baseline and 6 months
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Cardiac rehabilitation research center
Study officials:
affiliation: Cardiac Rehabilitation Research Center
name: Masoumeh Sadeghi, MD
role: PRINCIPAL_INVESTIGATOR
References: