Text Size

Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01086800
First received: March 12, 2010
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    • 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:
  • Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    • vitality
    • self reported sleepiness

  • Compare nocturnal supplemental oxygen and PAP on measures of: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    • efficacy (AHI, hypoxemia)
    • adherence
    • side effects


Enrollment: 318
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086800

Locations
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
Principal Investigator: Susan Redline, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Susan Redline, Senior Physician, Division of Sleep Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01086800     History of Changes
Other Study ID Numbers: 1RC2HL101417-01
Study First Received: March 12, 2010
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013