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| Name | Class |
|---|---|
| National Institute for Medical Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months |
|
| Placebo | Placebo Comparator | Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 10 mg | Drug | Melatonin tablets (10 mg) |
| |
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of melatonin | 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) | Measured by dual-energy x-ray absorptiometry |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting blood glucose level (mg/dl) | Measured in serum samples after 12h fasting | Baseline and 6 months |
| Change in serum lipid levels (mg/dl) | Including triglyceride, LDL, and HDL, measured in serum samples after 12h fasting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shervin Gh Hoseini, MD, PhD | Contact | 00989131081854 | shghaffari@yahoo.com | |
| Masoumeh Sadeghi, MD | Contact | 00983136115208 | sadeghimasoumeh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Masoumeh Sadeghi, MD | Cardiac Rehabilitation Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac rehabilitation research center | Recruiting | Isfahan | Iran |
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Six months after publication
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Placebo tablets manufactured the same as melatonin tablets |
|
| Baseline and 6 months |
| Change in lean body mass (kg) | Measured by bioimpedance analysis | Baseline and 3 months |
| Change in lean body mass (kg) | Measured by bioimpedance analysis | Baseline and 6 months |
| Change in grip strength (kg) | Measured by a hydraulic dynamometer | Baseline and 3 months |
| Change in grip strength (kg) | Measured by a hydraulic dynamometer | Baseline and 6 months |
| Change in exercise capacity | Measured by 6 minute walk test | Baseline and 3 months |
| Change in exercise capacity | Measured by 6 minute walk test | Baseline and 6 months |
| Change in Left ventricular ejection fraction (LVEF) | Measured by echocardiography using the Simpson method | Baseline and 6 months |
| Change in left ventricular end-systolic volume (LVESV) | Measured by echocardiography using the Simpson method | Baseline and 6 months |
| Change in endothelial dysfunction | Measured by flow-mediated vasodilation (FMD) method | Baseline and 6 months |
| Change in mean systolic and diastolic blood pressures | Mean of two measurements, using an automated electronic oscillometric device | Baseline and 3 months |
| Change in mean systolic and diastolic blood pressures | Mean of two measurements, using an automated electronic oscillometric device | Baseline and 6 months |
| Baseline and 6 months |
| 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 |
| Change in level of serum inflammatory biomarkers | 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 | Including malondialdehyde (MDA) and total antioxidant capacity (TAC) | Baseline and 6 months |
| 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 |
| Changes in sleep quality of the patients | Measured by Pittsburgh Sleep Quality Index (PSQI) questionnaire | Baseline and 6 months |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |