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Sponsors and Collaborators: |
Brigham and Women's Hospital American Academy of Sleep Medicine |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00869869 |
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.
Condition | Intervention | Phase |
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Heart Failure Sleep Disorders |
Drug: melatonin Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Restoration of Sleep in Heart Failure Patients |
Estimated Enrollment: | 16 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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melatonin: Experimental
melatonin
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Drug: melatonin
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
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placebo: Placebo Comparator
placebo
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Drug: placebo
placebo
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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.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erin E. Kelly, M.S. | 617-732-5737 | ekelly19@rics.bwh.harvard.edu |
Contact: Frank A.J.L. Scheer, Ph.D. | 617-732-7014 | fscheer@rics.bwh.harvard.edu |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Frank AJL Scheer, PhD |
Principal Investigator: | Frank A.J.L. Scheer, Ph.D. | Brigham and Women's Hospital, Harvard Medical School |
Responsible Party: | Brigham and Women's Hospital, Harvard Medical School ( Frank AJL Scheer, PhD/Instructor in Medicine ) |
Study ID Numbers: | ASMF-Scheer |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869869 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Signs and Symptoms Heart Failure Antioxidants Heart Diseases Mental Disorders |
Vascular Diseases Central Nervous System Depressants Neurologic Manifestations Sleep Disorders Melatonin |
Heart Failure Antioxidants Heart Diseases Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Sleep Disorders Central Nervous System Depressants Protective Agents |
Pharmacologic Actions Signs and Symptoms Mental Disorders Therapeutic Uses Neurologic Manifestations Cardiovascular Diseases Melatonin Central Nervous System Agents |