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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Effect of Melatonin on Cardiovascular and Muscle Function in Patients With Heart Failure: a Double Blinded Prospective Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894683
• Other study ID #: 397180
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2018
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Isfahan University of Medical Sciences
• Contact: Shervin Gh Hoseini, MD, PhD
• Phone: 00989131081854
• Email: shghaffari[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• Melatonin 10 mg
Melatonin tablets (10 mg)
• Placebo Oral Tablet
Placebo tablets manufactured the same as melatonin tablets

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cardiac rehabilitation research center	Isfahan

Sponsors (2)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences	National Institute for Medical Research Development

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fasting blood glucose level (mg/dl)	Measured in serum samples after 12h fasting	Baseline and 6 months
Other	Change in serum lipid levels (mg/dl)	Including triglyceride, LDL, and HDL, measured in serum samples after 12h fasting	Baseline and 6 months
Other	Change in serum insulin, and IGF-1 levels	Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°	Baseline and 6 months
Other	Change in level of serum inflammatory biomarkers	Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°	Baseline and 6 months
Other	Change in level of serum oxidative stress biomarkers	Including malondialdehyde (MDA) and total antioxidant capacity (TAC)	Baseline and 6 months
Other	Changes in psychological status of the patients	Including anxiety (by Spielberger State - Trait Anxiety Inventory (STAI)) and depression (by Beck Depression Inventory)	Baseline and 6 months
Other	Changes in sleep quality of the patients	Measured by Pittsburgh Sleep Quality Index (PSQI) questionnaire	Baseline and 6 months
Primary	Composite 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)	6 months or earlier if patient was dropped out from the study
Secondary	Adverse effects of melatonin	Adverse effects detected in the melatonin group compared with the placebo group	Throughout the study up to 6 months
Secondary	Change in appendicular lean mass (kg)	Measured by dual-energy x-ray absorptiometry	Baseline and 6 months
Secondary	Change in lean body mass (kg)	Measured by bioimpedance analysis	Baseline and 3 months
Secondary	Change in lean body mass (kg)	Measured by bioimpedance analysis	Baseline and 6 months
Secondary	Change in grip strength (kg)	Measured by a hydraulic dynamometer	Baseline and 3 months
Secondary	Change in grip strength (kg)	Measured by a hydraulic dynamometer	Baseline and 6 months
Secondary	Change in exercise capacity	Measured by 6 minute walk test	Baseline and 3 months
Secondary	Change in exercise capacity	Measured by 6 minute walk test	Baseline and 6 months
Secondary	Change in Left ventricular ejection fraction (LVEF)	Measured by echocardiography using the Simpson method	Baseline and 6 months
Secondary	Change in left ventricular end-systolic volume (LVESV)	Measured by echocardiography using the Simpson method	Baseline and 6 months
Secondary	Change in endothelial dysfunction	Measured by flow-mediated vasodilation (FMD) method	Baseline and 6 months
Secondary	Change in mean systolic and diastolic blood pressures	Mean of two measurements, using an automated electronic oscillometric device	Baseline and 3 months
Secondary	Change in mean systolic and diastolic blood pressures	Mean of two measurements, using an automated electronic oscillometric device	Baseline and 6 months