Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

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.

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