ResMed announced primary results from a multicenter, randomized controlled phase II trial known as CAT-HF presented at the European Society of Cardiology's 2016 Annual Heart Failure Congress. CAT-HF assessed whether the 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 symptoms (acute decompensated heart failure) over six months.
The results of the trial were presented as a late-breaking presentation by Christopher M. O'Connor, M.D., the principal investigator of the study and chief executive officer and executive director of the Inova Heart and Vascular Institute.
The overall study results were neutral (based on a hazard ratio [HR] =1.07, 95 percent confidence interval [95% CI] = (0.75, 1.51), p-value = 0.717). However, a pre-specified subgroup analysis showed a statistically significant improvement in the primary endpoint for people with heart failure with preserved ejection fraction who have sleep-disordered breathing (based on a HR = 0.38, 95% CI = (0.15, 0.98), p-value = 0.045).
"These results are important because they are the first to show that addressing sleep-disordered breathing with ASV therapy may improve cardiovascular outcomes for people with preserved ejection fraction heart failure," said ResMed chief medical officer, Glenn Richards, M.D. "We look forward to fully analyzing the results to better understand the role of addressing sleep-disordered breathing in patients with heart failure to determine who would be appropriate candidates for ASV therapy."
CAT-HF is the second randomized controlled ResMed-sponsored study examining the role of treating sleep-disordered breathing in people with heart failure. Last year, results were published from a phase IV study known as SERVE-HF that showed ASV therapy should not be used for patients with predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction.
"There are no level of evidence 1A guideline recommended therapies specific for heart failure with preserved ejection fraction, which accounts for half of all people living with chronic heart failure," O'Connor said. "These results from CAT-HF suggest we need to study the role of whether addressing sleep-disordered breathing can help people who have heart failure with preserved ejection fraction."
CAT-HF is a randomized controlled trial that evaluated whether adding adaptive servo-ventilation (ASV) to optimized medical therapy could improve cardiovascular outcomes at six months for people with acute decompensated heart failure (HF) patients compared to optimized medical therapy alone. Patients were enrolled with a prior or new diagnosis of heart failure after admission to the hospital with sudden worsening of heart failure symptoms.
The primary endpoint was cardiovascular outcomes measured as a Global Rank Score of six-minute walk distance, hospitalizations due to cardiovascular issues and death. The study also assessed changes in functional parameters, arrhythmias, biomarkers, quality of life (QoL), and sleep and breathing.
