Heart FailurePhase 2NCT00869869
Melatonin Supplementation to Improve Sleep in Patients With Heart Failure
A Phase 2 study testing melatonin in people with Heart Failure and Sleep Disorders, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Heart Failure, Sleep Disorders
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with heart failure NYHA Class 2 or 3
- Currently being treated with beta-blocker
Who cannot join
- Diagnosed with obstructive sleep apnea
- Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Restoration of Sleep in Heart Failure Patients
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.
Read the 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
- Heart Failure, Sleep Disorders
- Being tested
- melatonin, placebo
- 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
- Medical subject headings
- Heart Failure, Sleep Wake Disorders, Nervous System Diseases, Vascular Diseases, Signs and Symptoms, Mental Disorders, Neurologic Manifestations, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Experimental | melatonin Receives: Drug: melatonin |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quantity assessed by actigraphy
Measured: measured during ambulatory phase
Secondary outcomes (1)
Change in quality of life and heart failure biomarkers
Measured: measured during study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: No subjects were enrolled in this study. Funding ran out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank A.J.L. Scheer, Ph.D., Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869869
- Sponsor's protocol ID
- ASMF-Scheer
- Status last verified
- Jan 2018
- First submitted
- 25 Mar 2009
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14732734Scheer 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.
PubMed 15649734Scheer 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.
PubMed 16130027Scheer 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.
PubMed 16364835Scheer 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.
PubMed 17533214
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Sleep in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00869869
- Acronym / sponsor ID
- ASMF-Scheer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled in this study. Funding ran out.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin | Experimental | Drug: melatoninmelatonin |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with heart failure NYHA Class 2 or 3
- Currently being treated with beta-blocker
Key exclusion criteria (2 listed)
- Diagnosed with obstructive sleep apnea
- Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks | Drug | melatonin |
| placeboplacebo | Drug | placebo |
Primary outcome
Change in sleep quantity assessed by actigraphy
Time frame: measured during ambulatory phase
1 secondary outcome
Change in quality of life and heart failure biomarkers
Time frame: measured during study visits
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Background: PubMed 14732734Scheer 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.
- Background: PubMed 15649734Scheer 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.
- Background: PubMed 16130027Scheer 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.
- Background: PubMed 16364835Scheer 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.
- Background: PubMed 17533214Scheer 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.
- Faculty Profile: Frank A.J.L. Scheer, Ph.D.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A.J.L. Scheer, Ph.D. principal investigator
Brigham and Women's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin in people with Heart Failure and Sleep Disorders, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quantity assessed by actigraphy (time frame: measured during ambulatory phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869869, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.