Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869869
Recruitment Status : Withdrawn (No subjects were enrolled in this study. Funding ran out.)
First Posted : March 26, 2009
Last Update Posted : January 19, 2018
American Academy of Sleep Medicine
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Sleep Disorders Drug: melatonin Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Sleep in Heart Failure Patients
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin
Drug: melatonin
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks

Placebo Comparator: placebo
Drug: placebo

Primary Outcome Measures :
  1. Change in sleep quantity assessed by actigraphy [ Time Frame: measured during ambulatory phase ]

Secondary Outcome Measures :
  1. Change in quality of life and heart failure biomarkers [ Time Frame: measured during study visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869869

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
American Academy of Sleep Medicine
Principal Investigator: Frank A.J.L. Scheer, Ph.D. Brigham and Women's Hospital, Harvard Medical School

Additional Information:
Responsible Party: Frank AJL Scheer, PhD, Associate Professor of Medicine, Brigham and Women's Hospital Identifier: NCT00869869     History of Changes
Other Study ID Numbers: ASMF-Scheer
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:
Heart Failure
Sleep Disorders
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

Additional relevant MeSH terms:
Heart Failure
Sleep Wake Disorders
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs