Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

This study has been withdrawn prior to enrollment.
(No subjects were enrolled in this study. Funding ran out.)
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00869869
First received: March 25, 2009
Last updated: June 27, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Sleep in Heart Failure Patients

Resource links provided by NLM:


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 Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: melatonin
melatonin
Drug: melatonin
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
Placebo Comparator: placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Frank A.J.L. Scheer, Ph.D. Brigham and Women's Hospital, Harvard Medical School
  More Information

Additional Information:
Publications:
Responsible Party: Frank AJL Scheer, PhD/Instructor in Medicine, Brigham and Women's Hospital, Harvard Medical School
ClinicalTrials.gov Identifier: NCT00869869     History of Changes
Other Study ID Numbers: ASMF-Scheer
Study First Received: March 25, 2009
Last Updated: June 27, 2011
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

Additional relevant MeSH terms:
Heart Failure
Sleep Disorders
Parasomnias
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Melatonin
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Antioxidants
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014