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Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01086800
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : February 25, 2013
Sponsor:
Collaborators:
Case Western Reserve University
Partners HealthCare
Johns Hopkins University
VA Boston Healthcare System
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital

Study Description
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Brief Summary:
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Obstructive Sleep Apnea Coronary Artery Disease Other: Healthy Lifestyles and Sleep Education plus PAP Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen Other: Healthy Lifestyles and Sleep Education Phase 2

Detailed Description:

This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.

Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
HLSE plus PAP Other: Healthy Lifestyles and Sleep Education plus PAP
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.
HLSE plus Oxygen Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
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.
Healthy Lifestyles and Sleep Education Other: Healthy Lifestyles and Sleep Education
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.


Outcome Measures
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Primary Outcome Measures :
  1. To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: [ Time Frame: 3 months ]
    • 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


Secondary Outcome Measures :
  1. Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: [ Time Frame: 3 months ]
    • vitality
    • self reported sleepiness

  2. Compare nocturnal supplemental oxygen and PAP on measures of: [ Time Frame: 3 months ]
    • efficacy (AHI, hypoxemia)
    • adherence
    • side effects


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • established Coronary Artery Disease or established cardiovascular disease risk factors
  • home sleep test that showed moderately severe sleep apnea

Exclusion Criteria:

  • poorly controlled health
  • currently using supplemental oxygen or PAP for OSA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086800


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Partners HealthCare
Boston, Massachusetts, United States, 02115
VA Boston Healthcare System
Boston, Massachusetts, United States, 02132
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Brigham and Women's Hospital
Case Western Reserve University
Partners HealthCare
Johns Hopkins University
VA Boston Healthcare System
Investigators
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Principal Investigator: Susan Redline, MD, MPH Brigham and Women's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susan Redline, Senior Physician, Division of Sleep Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01086800    
Other Study ID Numbers: 1RC2HL101417-01 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cardiovascular Diseases
Coronary Artery Disease
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Coronary Disease
 Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases