ResMed announced publication of a study that investigated whether treatment of moderate to severe sleep-disordered breathing (obstructive or central sleep apnea) with adaptive servo-ventilation (ASV) therapy could improve cardiovascular outcomes in patients who were hospitalized for a sudden worsening of their heart failure (acute decompensated heart failure) over six months.* The study is published in in the Journal of the American College of Cardiology (JACC).
“Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure – The CAT-HF Trial” is a multicenter, randomized, controlled Phase II trial funded by ResMed to broaden the understanding of how best to treat diagnosed sleep apnea in patients that also have a particular form of heart failure.
The overall study results were neutral (Wilcoxon p-value = 0.717). However, the study revealed a pre-specified subgroup analysis that showed a statistically significant improvement in the primary endpoint for people with moderate to severe sleep-disordered breathing and heart failure with preserved ejection fraction (HFpEF) (Cox p-value = 0.036). The primary endpoint was cardiovascular outcomes measured as a Global Rank Score that included survival free from cardiovascular hospitalization and change in functional capacity as measured by the six-minute walk distance. The study also assessed changes in functional parameters, arrhythmias, biomarkers, quality of life (QoL), and sleep and breathing.
Leading cardiologists say the improvement for HFpEF patients with sleep apnea signals a potential breakthrough in treatment options for those patients, and call for more research to be done.
“There are no level of evidence 1A guideline recommended therapies specific for HFpEF patients, which accounts for half of all people living with chronic heart failure,” says Christopher M. O’Connor, MD, the study’s lead investigator, cardiologist and CEO of the Inova Heart and Vascular Institute, in a release. “These results from CAT-HF suggest we need to further study the role of whether addressing sleep-disordered breathing can help people who have heart failure with preserved ejection fraction.”
“This is another great step forward in understanding the connection between sleep-disordered breathing, heart failure and proper treatment methods,” says Tony DeMaria, MD, a cardiologist from the University of California – San Diego. “We are looking forward to what future heart failure research can tell us about key links to other conditions our patients face.”
“Having JACC publish this research is incredibly positive, encouraging others to look deeper into the potential benefits of ASV therapy,” says Carlos Nunez, MD, ResMed chief medical officer. “I hope future studies can further establish these benefits and lead to life-improving treatment recommendations for countless patients with sleep apnea.”
* The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing.