Henrik Fox1,2, Thomas Bitter3, Odile Sauzet4, Volker Rudolph5,3, Olaf Oldenburg3,6. 1. Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany. akleemeyer@hdz-nrw.de. 2. Heart Failure Department, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. akleemeyer@hdz-nrw.de. 3. Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 4. Epidemiology and International Public Health, Bielefeld School of Public Health and Statistical Consulting Centre, Bielefeld University, Bielefeld, Germany. 5. Heart Failure Department, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 6. Department of Cardiology, Clemenshospital, Ludgerus-Kliniken, Münster, Germany.
Abstract
BACKGROUND:Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality. OBJECTIVES: The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO2), percent-predicted peak VO2 and oxygen uptake at anaerobic threshold (VO2-AT). METHODS: This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months. RESULTS:76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO2 in comparison to control (67 ± 17 to 73 ± 19%; p = 0.01). Additional primary endpoints peak VO2 and VO2-AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively). CONCLUSION:APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO2, an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life.
RCT Entities:
BACKGROUND: Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failurepatients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality. OBJECTIVES: The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO2), percent-predicted peak VO2 and oxygen uptake at anaerobic threshold (VO2-AT). METHODS: This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months. RESULTS: 76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO2 in comparison to control (67 ± 17 to 73 ± 19%; p = 0.01). Additional primary endpoints peak VO2 and VO2-AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively). CONCLUSION:APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO2, an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life.
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