Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

Phase 2

Withdrawn

• Conditions: Sleep Disorders; Heart Failure
• Interventions: Drug: placebo; Drug: melatonin

• Registration Number: NCT00869869
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
melatonin	melatonin	melatonin

Primary Outcome Measures

Name	Time	Method
Change in sleep quantity assessed by actigraphy	measured during ambulatory phase

Secondary Outcome Measures

Name	Time	Method
Change in quality of life and heart failure biomarkers	measured during study visits

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States