Heart Biomarker Evaluation in Apnea Treatment
HeartBEAT
Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
1 other identifier
interventional
318
1 country
4
Brief Summary
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2010
4 active sites
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
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 25, 2013
February 1, 2013
1.9 years
March 12, 2010
February 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
* 24 hour blood pressure (BP) profile * Markers of systemic inflammation * Markers of oxidative stress * Prothrombotic markers * Sympathetic nervous system activity * Cardiac rhythm, impulse generation and ischemia * Dyslipidemia * Glucose regulation * Myocardial stress
3 months
Secondary Outcomes (2)
Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:
3 months
Compare nocturnal supplemental oxygen and PAP on measures of:
3 months
Study Arms (3)
HLSE plus PAP
OTHERHLSE plus Oxygen
OTHERHealthy Lifestyles and Sleep Education
OTHERInterventions
Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Eligibility Criteria
You may qualify if:
- established Coronary Artery Disease or established cardiovascular disease risk factors
- home sleep test that showed moderately severe sleep apnea
You may not qualify if:
- poorly controlled health
- currently using supplemental oxygen or PAP for OSA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Case Western Reserve Universitycollaborator
- Partners HealthCarecollaborator
- Johns Hopkins Universitycollaborator
- VA Boston Healthcare Systemcollaborator
Study Sites (4)
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Partners HealthCare
Boston, Massachusetts, 02115, United States
VA Boston Healthcare System
Boston, Massachusetts, 02132, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Related Publications (6)
Hilmisson H, Thomas RJ, Magnusdottir S. Cardiopulmonary coupling-calculated sleep stability and nocturnal heart rate kinetics as a potential indicator for cardiovascular health: a relationship with blood pressure dipping. Front Sleep. 2024 Aug 1;3:1230958. doi: 10.3389/frsle.2024.1230958. eCollection 2024.
PMID: 41424523DERIVEDNi YN, Lei F, Tang X, Liang Z, Thomas RJ. The association between the effective apnea-hypopnea index and blood pressure reduction efficacy following CPAP/oxygen treatment. Sleep Med. 2024 May;117:46-52. doi: 10.1016/j.sleep.2024.02.046. Epub 2024 Mar 13.
PMID: 38507976DERIVEDSchmickl CN, Orr JE, Sands SA, Alex RM, Azarbarzin A, McGinnis L, White S, Mazzotti DR, Nokes B, Owens RL, Gottlieb DJ, Malhotra A. Loop Gain as a Predictor of Blood Pressure Response in Patients Treated for Obstructive Sleep Apnea: Secondary Analysis of a Clinical Trial. Ann Am Thorac Soc. 2024 Feb;21(2):296-307. doi: 10.1513/AnnalsATS.202305-437OC.
PMID: 37938917DERIVEDMagnusdottir S, Thomas RJ, Hilmisson H. Can improvements in sleep quality positively affect serum adiponectin-levels in patients with obstructive sleep apnea? Sleep Med. 2021 Aug;84:324-333. doi: 10.1016/j.sleep.2021.05.032. Epub 2021 May 29.
PMID: 34225174DERIVEDMagnusdottir S, Hilmisson H, Thomas RJ. Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk. J Hypertens. 2020 Nov;38(11):2287-2294. doi: 10.1097/HJH.0000000000002553.
PMID: 32649638DERIVEDGottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
PMID: 24918372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Redline, MD, MPH
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician, Division of Sleep Medicine
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
February 1, 2010
Primary Completion
January 1, 2012
Study Completion
August 1, 2012
Last Updated
February 25, 2013
Record last verified: 2013-02