Melatonin Supplementation to Improve Sleep in Patients Wi... | NCT00869869

Studies
Melatonin Supplementation to Improve Sleep in Patients With Heart Failure

NCT00869869

Sponsor

Brigham and Women's Hospital

Status

Withdrawn

Last Update Posted

Jan 19, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Heart Failure
Sleep Disorders

Interventions

melatonin
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No subjects were enrolled in this study. Funding ran out.

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Mar 25, 2009

First Submission Date that Met QC Criteria

Mar 25, 2009

First Posted Date

Mar 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2018

Last Update Posted Date

Jan 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frank AJL Scheer, PhD, Associate Professor of Medicine, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
American Academy of Sleep Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

Conditions

Heart Failure
Sleep Disorders

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
melatonin	Experimental	melatonin	Drug: melatonin
placebo	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
melatonin	Drug	2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks	melatonin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in sleep quantity assessed by actigraphy		measured during ambulatory phase

Secondary Outcomes

Measure	Description	Time Frame
Change in quality of life and heart failure biomarkers		measured during study visits

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank A.J.L. Scheer, Ph.D.	Brigham and Women's Hospital, Harvard Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14732734	Background	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.
15649734	Background	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.

ID	Term
D006333	Heart Failure
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D014652	Vascular Diseases
D012816	Signs and Symptoms
D001523	Mental Disorders
D009461	Neurologic Manifestations
D002318	Cardiovascular Diseases

ID	Term
D006331	Heart Diseases
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring