ResMed Halts Sleep Apnea Trial Over Risks
San Diego, Calif-based ResMed announced Wednesday that it stopped its Serve-HF clinical trial for failing to meet a primary endpoint and for potentially putting patients at risk. The study was designed to evaluate whether a moderate to severe predominant central sleep apnea treatment could reduce death and illness in symptomatic chronic heart failure patients.
The trial did not demonstrate significant statistical difference in primary endpoints between patients who received the treatment and those in the control arm, the company says.
Additionally, preliminary analysis of the data indicates a significant difference between the two arms in absolute increased risk of cardiovascular mortality — those who received the treatment displayed a 2.5 percent higher rate.
The company says the Adaptive Servo-Ventilation device administering the therapy displayed no performance issues. It is investigating the matter and working with global regulatory authorities to update its labeling. This includes an ASV device contraindication for patients with symptomatic chronic heart failure. — Jason Scott