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Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure

NCT00733343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1325

Last updated 2020-05-12

Study results available
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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.

Conditions

Interventions

DEVICE

Europe: AutoSet CS (USA: VPAP Adapt SV)

At least 3 hours average daily usage time

Sponsors & Collaborators

  • CRI-The Clinical Research Institute GmbH

    collaborator INDUSTRY

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Helmut Teschler, Prof. · Universitätsklinikum Essen

  • Martin Cowie, Prof. · National Heart and Lung Institute (NHLI) Brompton Hospital, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Australia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Netherlands
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00733343 on ClinicalTrials.gov