Read an interview with Dr. Christopher M. O’Connor, CEO and executive director of Inova Heart & Vascular Institute, on medicalresearch.com.
There is minimal clinical evidence about identifying and treating sleep apnea in those who’ve been hospitalized with acute decompensated heart failure. The CAT-HF study was designed to help address this, with the primary endpoint being 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. It was also planned to expand on the SERVE-HF study that was investigating the use of ASV therapy to treat central sleep apnea (CSA) in chronic stable heart failure patients with reduced ejection fraction patients (HFrEF).
The CAT-HF study was stopped early based on the results of the SERVE-HF study, which showed an increased risk of cardiovascular mortality with use of ASV in patients with CSA and HFrEF. The primary endpoint of CAT-HF was neutral (Wilcoxon p-value = 0.717).
However, a pre-specified subgroup analysis showed a statistically significant improvement in the primary endpoint for people with moderate to severe sleep apnea and heart failure with preserved ejection fraction (HFpEF) (Cox p-value = 0.036).