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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Melatonin 10 mg
Placebo Oral Tablet
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Heart failure, Melatonin, Muscle wasting

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac rehabilitation research centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2019
Last Updated
March 27, 2019
Sponsor
Isfahan University of Medical Sciences
Collaborators
National Institute for Medical Research Development
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1. Study Identification

Unique Protocol Identification Number
NCT03894683
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
National Institute for Medical Research Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
Heart failure, Melatonin, Muscle wasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.
Intervention Type
Drug
Intervention Name(s)
Melatonin 10 mg
Intervention Description
Melatonin tablets (10 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo tablets manufactured the same as melatonin tablets
Primary Outcome Measure Information:
Title
Composite clinical endpoint score
Description
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
Secondary Outcome Measure Information:
Title
Adverse effects of melatonin
Description
Adverse effects detected in the melatonin group compared with the placebo group
Time Frame
Throughout the study up to 6 months
Title
Change in appendicular lean mass (kg)
Description
Measured by dual-energy x-ray absorptiometry
Time Frame
Baseline and 6 months
Title
Change in lean body mass (kg)
Description
Measured by bioimpedance analysis
Time Frame
Baseline and 3 months
Title
Change in lean body mass (kg)
Description
Measured by bioimpedance analysis
Time Frame
Baseline and 6 months
Title
Change in grip strength (kg)
Description
Measured by a hydraulic dynamometer
Time Frame
Baseline and 3 months
Title
Change in grip strength (kg)
Description
Measured by a hydraulic dynamometer
Time Frame
Baseline and 6 months
Title
Change in exercise capacity
Description
Measured by 6 minute walk test
Time Frame
Baseline and 3 months
Title
Change in exercise capacity
Description
Measured by 6 minute walk test
Time Frame
Baseline and 6 months
Title
Change in Left ventricular ejection fraction (LVEF)
Description
Measured by echocardiography using the Simpson method
Time Frame
Baseline and 6 months
Title
Change in left ventricular end-systolic volume (LVESV)
Description
Measured by echocardiography using the Simpson method
Time Frame
Baseline and 6 months
Title
Change in endothelial dysfunction
Description
Measured by flow-mediated vasodilation (FMD) method
Time Frame
Baseline and 6 months
Title
Change in mean systolic and diastolic blood pressures
Description
Mean of two measurements, using an automated electronic oscillometric device
Time Frame
Baseline and 3 months
Title
Change in mean systolic and diastolic blood pressures
Description
Mean of two measurements, using an automated electronic oscillometric device
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Change in fasting blood glucose level (mg/dl)
Description
Measured in serum samples after 12h fasting
Time Frame
Baseline and 6 months
Title
Change in serum lipid levels (mg/dl)
Description
Including triglyceride, LDL, and HDL, measured in serum samples after 12h fasting
Time Frame
Baseline and 6 months
Title
Change in serum insulin, and IGF-1 levels
Description
Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Time Frame
Baseline and 6 months
Title
Change in level of serum inflammatory biomarkers
Description
Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Time Frame
Baseline and 6 months
Title
Change in level of serum oxidative stress biomarkers
Description
Including malondialdehyde (MDA) and total antioxidant capacity (TAC)
Time Frame
Baseline and 6 months
Title
Changes in psychological status of the patients
Description
Including anxiety (by Spielberger State - Trait Anxiety Inventory (STAI)) and depression (by Beck Depression Inventory)
Time Frame
Baseline and 6 months
Title
Changes in sleep quality of the patients
Description
Measured by Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shervin Gh Hoseini, MD, PhD
Phone
00989131081854
Email
shghaffari@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Masoumeh Sadeghi, MD
Phone
00983136115208
Email
sadeghimasoumeh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoumeh Sadeghi, MD
Organizational Affiliation
Cardiac Rehabilitation Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac rehabilitation research center
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
masoumeh sadeghi, M.D.
Email
sadeghimasoumeh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Six months after publication

Learn more about this trial

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

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