Project 170503

Adaptive servo ventilation for therapy of sleep apnea in heart failure

170503

Adaptive servo ventilation for therapy of sleep apnea in heart failure

$1,583,255
Project Information
Study Type: Interventional Randomized_Controlled_Trial
Therapeutic Area: Cardiology
Research Theme: Clinical
Disease Area: heart failure, sleep apnea
Data Type: International
Abstract Summary

Heart failure (HF) affects 2% Canadians and is now the second leading cause of death. It is therefore important to identify potentially treatable factors that could improve the outcome of this disease. Obstructive and central sleep apnea (OSA and CSA, respectively) may be 2 such factors. They occur in approximately 50% of patients with heart failure (HF), where they increase the risk of premature death. Previous studies have shown that treating these 2 breathing disorders with continuous positive airway pressure (CPAP) improves heart function. However, owing to the small number of patients studied, and that CPAP is ineffective in alleviating CSA in many patients, these studies did not demonstrate that treating OSA or CSA reduces morbidity and mortality. Nevertheless, among HF patients with CSA, when CPAP did eliminate CSA, survival improved. Thus, there seems to be potential for treating OSA and CSA to improve survival in HF patients. Adaptive servo ventilation (ASV) is a new device that is equally effective in alleviating OSA, but more effective in alleviating CSA than CPAP. We therefore believe that this device has a greater chance to improve survival than CPAP. Accordingly, we will test the effects of ASV on death and hospitalization rates in 860 HF patients with OSA or CSA in 25 centres in Canada and 6 other countries. Positive results would fundamentally alter the way HF is investigated and treated.

Research Characteristics

This project includes the following research characteristics:

Digital Health
Wearable Technology
Health Technology Assessment
Resource Utilization
Health System Integration
Patient Reported Outcomes
Real World Evidence
Industry Partnership
Patient Engagement
International Collaboration
International Network
Safety Focus
Quality of Life
Biomarker Endpoints
Time to Event
Composite Endpoint
Vulnerable Populations
Study Justification

"heart failure affects 2% Canadians and is now the second leading cause of death, and sleep apnea occurs in approximately 50% of patients with heart failure where they increase the risk of premature death"

Novelty Statement

"testing adaptive servo ventilation device that is equally effective in alleviating OSA but more effective in alleviating CSA than CPAP in heart failure patients"

Keywords
Adaptive Servo Ventilation Central Sleep Apnea Heart Failure Obstructive Sleep Apnea Randomized Trial