Melatonin Supplementation to Improve Sleep in Patients With Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Restoration of Sleep in Heart Failure Patients|
- Change in sleep quantity assessed by actigraphy [ Time Frame: measured during ambulatory phase ] [ Designated as safety issue: No ]
- Change in quality of life and heart failure biomarkers [ Time Frame: measured during study visits ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
Placebo Comparator: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869869
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Frank A.J.L. Scheer, Ph.D.||Brigham and Women's Hospital, Harvard Medical School|