ResMed‘s Phase III SERVE-HF trial of adaptive servo-ventilation (ASV) therapy in central sleep apnea and chronic heart failure did not achieve its primary efficacy endpoint.
The trial aimed to assess whether treating moderate-to-severe predominant sleep apnea with ASV therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure.
The study failed to show a statistically significant difference between patients randomised to ASV therapy and those in the control group in the primary endpoint of time to all-cause mortality or unplanned hospitalisation for worsening heart failure.
According to preliminary analysis of data, patients who received ASV therapy were at statistically significant 2.5% absolute increased risk of cardiovascular mortality per year compared to those in the control group.
The cardiovascular mortality rate in the ASV group was 10% every year compared to 7.5% per year in the control group.
ResMed chief medical officer Dr Glenn Richards said: "The safety signal in SERVE-HF was observed only with the use of ASV therapy in people who have predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction.
"We are further analysing the data to understand why this unexpected result was observed in this trial."
Co-principal investigator Martin Cowie said: "SERVE-HF did not meet its primary endpoint. However this study provides valuable, practice-changing guidance on how to best care for people with chronic heart failure.
"SERVE-HF was a well-designed and executed study and because of it we now know that ASV therapy should not be used to treat central sleep apnea in people with symptomatic chronic heart failure with reduced ejection fraction."
The cardiovascular safety signal observed in the study was found only with ASV therapy in patients with moderate to severe predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction.
ResMed is currently working with global regulatory authorities to proactively revise labels and instructions for use of its ASV devices to include a contraindication for people with symptomatic chronic heart failure.
The company, which is also informing healthcare providers, physicians and patients of the safety signal observed in SERVE-HF, plans to submit results for publication after further analysis.