Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT)

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

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.

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.

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.

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.

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

Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:

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

Magnusdottir S, Thomas RJ, Hilmisson H. Can improvements in sleep quality positively affect serum adiponectin-levels in patients with obstructive sleep apnea? Sleep Med. 2021 Aug;84:324-333. doi: 10.1016/j.sleep.2021.05.032. Epub 2021 May 29.

Magnusdottir S, Hilmisson H, Thomas RJ. Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk. J Hypertens. 2020 Nov;38(11):2287-2294. doi: 10.1097/HJH.0000000000002553.

Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.