CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,325 enrolled
Drug / intervention
Europe: AutoSet CS (USA: VPAP Adapt SV)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00733343
NCT00733343N/ACompleted

Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

ResMed·interventional·Posted Aug 13, 2008·Updated May 12, 2020

In Brief

A clinical study evaluating Europe: AutoSet CS (USA: VPAP Adapt SV) for Heart Failure and Sleep Disordered Breathing. Completed, enrolled 1,325 participants across 267 sites in 11 countries.

Detailed Summary

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Czechia, Denmark, Finland, France, Germany, Netherlands, Norway, Sweden, Switzerland, United Kingdom

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2008
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 17.9 years ago

Interventions

Europe: AutoSet CS (USA: VPAP Adapt SV)device

At least 3 hours average daily usage time