NCT00869869

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

March 25, 2009

Last Update Submit

January 17, 2018

Conditions

Heart FailureSleep Disorders

Keywords

Heart FailureSleep DisordersMelatoninAntioxidantsMolecular Mechanisms of Pharmacological ActionNervous System DiseasesPhysiological Effects of DrugsVascular DiseasesCentral Nervous System DepressantsProtective AgentsPharmacologic ActionsSigns and SymptomsMental DisordersTherapeutic UsesNeurologic ManifestationsCardiovascular DiseasesCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • Change in sleep quantity assessed by actigraphy

    measured during ambulatory phase

Secondary Outcomes (1)

  • Change in quality of life and heart failure biomarkers

    measured during study visits

Study Arms (2)

melatonin

EXPERIMENTAL

melatonin

Drug: melatonin

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

melatoninDRUG

2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks

melatonin
placeboDRUG

placebo

placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with heart failure NYHA Class 2 or 3
  • Currently being treated with beta-blocker

You may not qualify if:

  • Diagnosed with obstructive sleep apnea
  • Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

  • 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.

    PMID: 14732734BACKGROUND

  • 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.

    PMID: 15649734BACKGROUND

  • 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.

    PMID: 16130027BACKGROUND

  • 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.

    PMID: 16364835BACKGROUND

  • 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.

    PMID: 17533214BACKGROUND

MeSH Terms

Conditions

Heart FailureSleep Wake DisordersNervous System DiseasesVascular DiseasesSigns and SymptomsMental DisordersNeurologic ManifestationsCardiovascular Diseases

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Heart DiseasesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Frank A.J.L. Scheer, Ph.D.

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(1)