Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

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

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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