Oxygen Versus PAP for Sleep Apnea in Heart Failure — OPTIMAL-HF  

Heart Failure Clinical Trial

Official title: Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure

Status Completed

Clinical Trial Summary

The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.

Clinical Trial Description

Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. At the outset of this study, there were three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk. ;

Related Conditions & MeSH terms

• Apnea
• Heart Failure
• Sleep Apnea Syndromes

• NCT number: NCT01807897
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2014
• Completion date: June 30, 2020