Clinical Trials Logo
  1. Home
  2. Heart Failure
  3. NCT00869869
  4. Details
NCT00869869 Clinical Trial

Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:
Restoration of Sleep in Heart Failure Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00869869
Other study ID # ASMF-Scheer
Secondary ID
Status Withdrawn
Phase Phase 2
First received March 25, 2009
Last updated January 17, 2018
Start date March 2009
Est. completion date March 2011

Study information
Verified date January 2018
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2011
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 35 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Brigham and Women's Hospital American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

Scheer FA, Czeisler CA. Melatonin, sleep, and circadian rhythms. Sleep Med Rev. 2005 Feb;9(1):5-9. Review. — View 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. — View 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. Epub 2004 Jan 19. — View 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. — View Citation

Scheer FA. Potential use of melatonin as adjunct antihypertensive therapy. Am J Hypertens. 2005 Dec;18(12 Pt 1):1619-20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in sleep quantity assessed by actigraphy measured during ambulatory phase
Secondary Change in quality of life and heart failure biomarkers measured during study visits
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

External Links