NCT03195660

Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.

Detailed description

Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036). Although the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.

Conditions

• Heart Failure With Normal Ejection Fraction
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	ASV Therapy	AirCurve 10 ASV device set up in AutoSet mode

Timeline

• Start date: 2017-06-26
• Primary completion: 2017-11-15
• Completion: 2017-11-15
• First posted: 2017-06-22
• Last updated: 2021-05-14
• Results posted: 2021-05-14

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study