Trials / Withdrawn
WithdrawnNCT00869869
Melatonin Supplementation to Improve Sleep in Patients With Heart Failure
Restoration of Sleep in Heart Failure Patients
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | melatonin | 2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-03-01
- Completion
- 2011-03-01
- First posted
- 2009-03-26
- Last updated
- 2018-01-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00869869. Inclusion in this directory is not an endorsement.