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Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

Mass General Brigham logo

Mass General Brigham

Status and phase

Completed
Phase 2

Conditions

Coronary Artery Disease
Obstructive Sleep Apnea
Cardiovascular Disease

Treatments

Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
Other: Healthy Lifestyles and Sleep Education
Other: Healthy Lifestyles and Sleep Education plus PAP

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01086800
1RC2HL101417-01

Details and patient eligibility

About

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

Full 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.

Enrollment

318 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

318 participants in 3 patient groups

HLSE plus PAP
Other group
Treatment:
Other: Healthy Lifestyles and Sleep Education plus PAP
HLSE plus Oxygen
Other group
Treatment:
Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
Healthy Lifestyles and Sleep Education
Other group
Treatment:
Other: Healthy Lifestyles and Sleep Education

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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