Heart Biomarker Evaluation in Apnea Treatment

Coronary Artery Disease Clinical Trial

— HeartBEAT  

Official title:

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086800
• Other study ID #: 1RC2HL101417-01
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2010
• Last updated: February 21, 2013
• Start date: February 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Partners HealthCare	Boston	Massachusetts
United States	VA Boston Healthcare System	Boston	Massachusetts
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Case Western Reserve University, Johns Hopkins University, Partners HealthCare, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:	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	No
Secondary	Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:	vitality; self reported sleepiness	3 months	No
Secondary	Compare nocturnal supplemental oxygen and PAP on measures of:	efficacy (AHI, hypoxemia); adherence; side effects	3 months	No