Clinical trial NCT00869869: Melatonin Supplementation to Improve Sleep in Patients With Heart Failure
Official title: Restoration of Sleep in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heart Failure
Sleep Disorders
Keywords: 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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2009-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep quantity assessed by actigraphy
timeFrame: measured during ambulatory phase
Secondary outcomes:
measure: Change in quality of life and heart failure biomarkers
timeFrame: measured during study visits
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Frank A.J.L. Scheer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.