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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months

Group Type EXPERIMENTAL

Melatonin 10 mg

Intervention Type DRUG

Melatonin tablets (10 mg)

Placebo

Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablets manufactured the same as melatonin tablets

Interventions

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Melatonin 10 mg

Melatonin tablets (10 mg)

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablets manufactured the same as melatonin tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No