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Completed

NCT Number: NCT01086800

Heart Biomarker Evaluation in Apnea Treatment

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

Completed

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Key information

Conditions

Cardiovascular Disease Apnea Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyssomnias Heart Diseases Myocardial Ischemia Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Lifestyles and Sleep Education plus PAP

Other

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.

Healthy Lifestyles and Sleep Education plus Supplemental Oxygen

Other

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Case Western Reserve University
  • Johns Hopkins University
  • Partners HealthCare
  • VA Boston Healthcare System

Registry information

Official study title

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Acronym: HeartBEAT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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