Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

February 21, 2013 updated by: Susan Redline, Brigham and Women's Hospital

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Partners HealthCare
      • Boston, Massachusetts, United States, 02132
        • VA Boston Healthcare System
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
Compare nocturnal supplemental oxygen and PAP on measures of:
Time Frame: 3 months
  • efficacy (AHI, hypoxemia)
  • adherence
  • side effects
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Investigators

  • Principal Investigator: Susan Redline, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1RC2HL101417-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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