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Sept. 3, 2013 /PRNewswire/ -- ResMed (NYSE: RMD), a pioneer and global leader in sleep and respiratory medicine, announced today at the European Society of Cardiology Congress 2013, that SERVE-HF has completed enrollment.
1 SERVE-HF is an international, randomized study of 1,325 participants investigating if the treatment of central sleep-disordered breathing (central sleep apnea) improves survival and outcomes of patients with stable heart failure.
Approximately 14 million people in
Europe are living with heart failure
2 and central sleep-disordered breathing is known to be a highly prevalent comorbidity in these patients. With an estimated 30-50 percent of heart failure patients potentially at risk,
3,4,5 the results from SERVE-HF may have important consequences for the future management of these patients.
"Completing recruitment of SERVE-HF has been an important milestone in this landmark trial," said co-principal investigator, Professor
Martin Cowie of the Royal Brompton Hospital in
London. "We owe much to the commitment and dedication of SERVE-HF investigators and to a strong collaboration between sleep specialists and cardiologists. We now look forward to results in 2016 and to a fuller understanding of just how important the treatment of central sleep-disordered breathing is in heart failure patients."
SERVE-HF will, for the first time, provide conclusive evidence of the health impact of effectively treating heart failure patients who have central sleep-disordered breathing. The trial, which began in 2008, is sponsored by ResMed. Designed as an event-driven study, its completion is anticipated by mid-2015 and results are expected to be available in the first half of 2016.
Central sleep-disordered breathing (central sleep apnea) Studies have demonstrated that patients with an abnormal waxing and waning breathing pattern, called central sleep apnea with Cheyne–Stokes respiration (CSA-CSR), have a poorer quality of life and increased mortality.
6,7,8 Between 30-50 percent of patients with heart failure may suffer from central sleep-disordered breathing
,3,4,5 meaning that this condition likely applies to millions of patients across
Europe living with stable heart failure. However, studies so far have indicated that treatment of CSA-CSR with PaceWave
TM Adaptive Servo-Ventilation (ASV) during sleep normalizes breathing, controls sleep-disordered breathing, improves cardiac function
7 and may lead to increased survival and better quality of life.
8,9,10About SERVE-HF 11SERVE-HF is being conducted across more than 80 sites in
France, the UK,
the Netherlands and the
The primary goal of the study is to determine whether managing CSA-CSR with ResMed's PaceWave
™ proprietary Minute Ventilation ASV technology (found in its AutoSet CS™ and VPAP™ Adapt devices) increases survival rates and decreases the burden of hospitalizations in this patient population. ASV is an intelligent method of non-invasive ventilation that continuously monitors and stabilizes the breathing patterns of individuals with sleep-disordered breathing throughout the night.
"The aim of SERVE-HF is to not only assess survival rates, but also to see if Adaptive Servo-Ventilation improves quality of life, sleep and physiologic changes associated with heart failure," said Professor Cowie. "Additionally, a health economic analysis will be performed to evaluate the potential economic benefits of therapy."