Melatonin Supplementation to Improve Sleep in Patients With Heart Failure
NCT ID: NCT00869869
Last Updated: 2018-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2009-03-31
2011-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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melatonin
melatonin
melatonin
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
placebo
placebo
placebo
placebo
Interventions
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melatonin
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Currently being treated with beta-blocker
Exclusion Criteria
* Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers
35 Years
75 Years
ALL
No
Sponsors
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American Academy of Sleep Medicine
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Frank AJL Scheer, PhD
Associate Professor of Medicine
Principal Investigators
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Frank A.J.L. Scheer, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Harvard Medical School
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Scheer FA, Van Montfrans GA, van Someren EJ, Mairuhu G, Buijs RM. Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension. Hypertension. 2004 Feb;43(2):192-7. doi: 10.1161/01.HYP.0000113293.15186.3b. Epub 2004 Jan 19.
Scheer FA, Czeisler CA. Melatonin, sleep, and circadian rhythms. Sleep Med Rev. 2005 Feb;9(1):5-9. doi: 10.1016/j.smrv.2004.11.004. No abstract available.
Scheer FA, Zeitzer JM, Ayas NT, Brown R, Czeisler CA, Shea SA. Reduced sleep efficiency in cervical spinal cord injury; association with abolished night time melatonin secretion. Spinal Cord. 2006 Feb;44(2):78-81. doi: 10.1038/sj.sc.3101784.
Scheer FA. Potential use of melatonin as adjunct antihypertensive therapy. Am J Hypertens. 2005 Dec;18(12 Pt 1):1619-20. doi: 10.1016/j.amjhyper.2005.07.013. No abstract available.
Scheer FA, Stone PH, Shea SA. Decreased sleep in heart failure: are medications to blame? Arch Intern Med. 2007 May 28;167(10):1098-9; author reply 1099-100. doi: 10.1001/archinte.167.10.1098-b. No abstract available.
Other Identifiers
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ASMF-Scheer
Identifier Type: -
Identifier Source: org_study_id
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