Melatonin Supplementation to Improve Sleep in Patients With Heart Failure - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital American Academy of Sleep Medicine
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00869869

Purpose

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
Heart Failure Sleep Disorders	Drug: melatonin Drug: placebo	Phase II

MedlinePlus related topics: Heart Failure Sleep Disorders

Drug Information available for: Melatonin

U.S. FDA Resources

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

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Change in sleep quantity assessed by actigraphy [ Time Frame: measured during ambulatory phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in quality of life and heart failure biomarkers [ Time Frame: measured during study visits ] [ Designated as safety issue: No ]

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
melatonin: Experimental melatonin	Drug: melatonin 2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
placebo: Placebo Comparator placebo	Drug: placebo placebo

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

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869869

Contacts

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

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Frank AJL Scheer, PhD

Sponsors and Collaborators

Brigham and Women's Hospital

American Academy of Sleep Medicine

Investigators

Principal Investigator:

Frank A.J.L. Scheer, Ph.D.

Brigham and Women's Hospital, Harvard Medical School

More Information

Additional Information:

Faculty Profile: Frank A.J.L. Scheer, Ph.D. This link exits the ClinicalTrials.gov site

Medical Chronobiology Program This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2004 Jan 19.

Scheer FA, Czeisler CA. Melatonin, sleep, and circadian rhythms. Sleep Med Rev. 2005 Feb;9(1):5-9. Review. 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.

Scheer FA. Potential use of melatonin as adjunct antihypertensive therapy. Am J Hypertens. 2005 Dec;18(12 Pt 1):1619-20. 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. No abstract available.

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

Keywords provided by Brigham and Women's Hospital:

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

Study placed in the following topic categories:

Signs and Symptoms
Heart Failure
Antioxidants
Heart Diseases
Mental Disorders

Vascular Diseases
Central Nervous System Depressants
Neurologic Manifestations
Sleep Disorders
Melatonin

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009