Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether melatonin can improve sleep, quality of life and markers of heart failure in patients with heart failure.

Detailed Description
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Heart failure affects nearly 5 million individuals in the United States and constitutes a prime risk factor for morbidity and mortality. Beta-blockers are a class of drugs that form a critical part of the best treatment of heart failure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Most patients with heart failure take beta-blockers and have poor sleep, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with heart failure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in improving quality of life and measures of heart failure. Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. The study will mainly take place at home, where participants will complete sleep diaries, measure blood pressure and wear a wrist watch that measures movement for 5-6 weeks. During that time there will be three visits to the hospital where plasma and urine samples will be collected and questionnaires will be completed.

Official Title
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Restoration of Sleep in Heart Failure Patients

Conditions
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Heart Failure, Sleep Disorders

Intervention / Treatment
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* Drug: melatonin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with heart failure NYHA Class 2 or 3 Currently being treated with beta-blocker Exclusion Criteria: Diagnosed with obstructive sleep apnea Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin<br>melatonin | Drug: melatonin<br>* 2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quantity assessed by actigraphy |  | measured during ambulatory phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life and heart failure biomarkers |  | measured during study visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Sleep Disorders, Melatonin, Antioxidants, Molecular Mechanisms of Pharmacological Action, Nervous System Diseases, Physiological Effects of Drugs, Vascular Diseases, Central Nervous System Depressants, Protective Agents, Pharmacologic Actions, Signs and Symptoms, Mental Disorders, Therapeutic Uses, Neurologic Manifestations, Cardiovascular Diseases, Central Nervous System Agents