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Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

NCT01128816 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2022-11-22

No results posted yet for this study

Summary

Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.

Conditions

Interventions

DEVICE

Adaptive Servo Ventilation

BiPAP autoSV ADVANCED device worn nightly during sleep

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Philips Respironics

    collaborator INDUSTRY

  • Toronto Rehabilitation Institute

    lead OTHER

Principal Investigators

  • Douglas Bradley, M.D. · Toronto Rehabilitation Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United States
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • 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 NCT01128816 on ClinicalTrials.gov