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

March 12, 2010
February 21, 2013
February 2010
January 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01086800 on ClinicalTrials.gov Archive Site
  • 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
  • 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
    • 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
Not Provided
Not Provided
 
Heart Biomarker Evaluation in Apnea Treatment
Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Cardiovascular Disease
  • Obstructive Sleep Apnea
  • Coronary Artery Disease
  • 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.
  • 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.
  • 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.
  • HLSE plus PAP
    Intervention: Other: Healthy Lifestyles and Sleep Education plus PAP
  • HLSE plus Oxygen
    Intervention: Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
  • Healthy Lifestyles and Sleep Education
    Intervention: Other: Healthy Lifestyles and Sleep Education
Gottlieb 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
August 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01086800
1RC2HL101417-01
Yes
Susan Redline, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Case Western Reserve University
  • Partners HealthCare
  • Johns Hopkins University
  • VA Boston Healthcare System
Principal Investigator: Susan Redline, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP