- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894683
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Shervin Gh Hoseini, MD, PhD
- Phone Number: 00989131081854
- Email: shghaffari@yahoo.com
Study Contact Backup
- Name: Masoumeh Sadeghi, MD
- Phone Number: 00983136115208
- Email: sadeghimasoumeh@gmail.com
Study Locations
-
-
-
Isfahan, Iran, Islamic Republic of
- Recruiting
- Cardiac rehabilitation research center
-
Contact:
- masoumeh sadeghi, M.D.
- Email: sadeghimasoumeh@gmail.com
-
-
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 397180
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.
Clinical Trials on Heart Failure With Reduced Ejection Fraction
-
Novartis PharmaceuticalsCompletedHeart Failure With Reduced Ejection Fraction (HFrEF) | or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)Netherlands, United States
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Medical University of South CarolinaCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Massachusetts General HospitalRoche DiagnosticsRecruitingCardiovascular Risk Factor | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Heart Failure, Right Sided | Heart Failure With Mid Range Ejection FractionUnited States
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on Melatonin 10 mg
-
Khon Kaen UniversityGeneral Drugs House Co.,LTD.; Ubon Ratchathani Cancer Hospital, Ubon RatchathaniCompletedHead and Neck CancerThailand
-
Lars Peter Holst AndersenUniversity of CopenhagenCompleted
-
Khon Kaen UniversityThailand Research Fund; Srinagarind Hospital, Khon Kaen University; Khon Kaen... and other collaboratorsCompletedAdvanced Stage CancerThailand
-
Khon Kaen UniversityUnknownPharmacokinetics of MelatoninThailand
-
University Health Network, TorontoUnknownPain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.Canada
-
Karolinska InstitutetCompleted
-
Ain Shams UniversityRecruiting
-
University of AarhusNot yet recruitingOsteoporosis, Postmenopausal
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro Social; Instituto de Seguridad y Servicios Sociales... and other collaboratorsRecruiting
-
Montefiore Medical CenterRecruitingPain, Postoperative | Narcotic UseUnited States