HeartBEAT: Heart Biomarker Evaluation in Apnea Treatment

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01086800

Collaborator

Case Western Reserve University (Other), Partners HealthCare (Other), Johns Hopkins University (Other), VA Boston Healthcare System (U.S. Fed)

318

Enrollment

Locations

Arms

Duration (Months)

79.5

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Obstructive Sleep Apnea Coronary Artery Disease	Other: Healthy Lifestyles and Sleep Education plus PAP Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen Other: Healthy Lifestyles and Sleep Education	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: [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 Outcome Measures

Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: [3 months]
vitality self reported sleepiness
Compare nocturnal supplemental oxygen and PAP on measures of: [3 months]
efficacy (AHI, hypoxemia) adherence side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21224
2	Partners HealthCare	Boston	Massachusetts	United States	02115
3	VA Boston Healthcare System	Boston	Massachusetts	United States	02132
4	Case Western Reserve University	Cleveland	Ohio	United States	44106