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

March 27, 2019 updated by: Masoumeh Sadeghi, Isfahan University of Medical Sciences

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months
Melatonin tablets (10 mg)
Placebo Comparator: Placebo
Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.
Placebo tablets manufactured the same as melatonin tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical endpoint score
Time Frame: 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)
6 months or earlier if patient was dropped out from the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects of melatonin
Time Frame: Throughout the study up to 6 months
Adverse effects detected in the melatonin group compared with the placebo group
Throughout the study up to 6 months
Change in appendicular lean mass (kg)
Time Frame: Baseline and 6 months
Measured by dual-energy x-ray absorptiometry
Baseline and 6 months
Change in lean body mass (kg)
Time Frame: Baseline and 3 months
Measured by bioimpedance analysis
Baseline and 3 months
Change in lean body mass (kg)
Time Frame: Baseline and 6 months
Measured by bioimpedance analysis
Baseline and 6 months
Change in grip strength (kg)
Time Frame: Baseline and 3 months
Measured by a hydraulic dynamometer
Baseline and 3 months
Change in grip strength (kg)
Time Frame: Baseline and 6 months
Measured by a hydraulic dynamometer
Baseline and 6 months
Change in exercise capacity
Time Frame: Baseline and 3 months
Measured by 6 minute walk test
Baseline and 3 months
Change in exercise capacity
Time Frame: Baseline and 6 months
Measured by 6 minute walk test
Baseline and 6 months
Change in Left ventricular ejection fraction (LVEF)
Time Frame: Baseline and 6 months
Measured by echocardiography using the Simpson method
Baseline and 6 months
Change in left ventricular end-systolic volume (LVESV)
Time Frame: Baseline and 6 months
Measured by echocardiography using the Simpson method
Baseline and 6 months
Change in endothelial dysfunction
Time Frame: Baseline and 6 months
Measured by flow-mediated vasodilation (FMD) method
Baseline and 6 months
Change in mean systolic and diastolic blood pressures
Time Frame: Baseline and 3 months
Mean of two measurements, using an automated electronic oscillometric device
Baseline and 3 months
Change in mean systolic and diastolic blood pressures
Time Frame: Baseline and 6 months
Mean of two measurements, using an automated electronic oscillometric device
Baseline and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting blood glucose level (mg/dl)
Time Frame: Baseline and 6 months
Measured in serum samples after 12h fasting
Baseline and 6 months
Change in serum lipid levels (mg/dl)
Time Frame: Baseline and 6 months
Including triglyceride, LDL, and HDL, measured in serum samples after 12h fasting
Baseline and 6 months
Change in serum insulin, and IGF-1 levels
Time Frame: Baseline and 6 months
Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Baseline and 6 months
Change in level of serum inflammatory biomarkers
Time Frame: Baseline and 6 months
Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Baseline and 6 months
Change in level of serum oxidative stress biomarkers
Time Frame: Baseline and 6 months
Including malondialdehyde (MDA) and total antioxidant capacity (TAC)
Baseline and 6 months
Changes in psychological status of the patients
Time Frame: Baseline and 6 months
Including anxiety (by Spielberger State - Trait Anxiety Inventory (STAI)) and depression (by Beck Depression Inventory)
Baseline and 6 months
Changes in sleep quality of the patients
Time Frame: Baseline and 6 months
Measured by Pittsburgh Sleep Quality Index (PSQI) questionnaire
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Masoumeh Sadeghi, MD, Cardiac rehabilitation research center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Six months after publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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