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Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

NCT01164592 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2015-08-07

No results posted yet for this study

Summary

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Conditions

Interventions

DEVICE

adaptive servoventilation (ASV)

Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Martin Cowie, Prof · Royal Brompton Hospital, London

  • Holger Woehrle, MD · ResMed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Australia
  • Czechia
  • Finland
  • France
  • Germany
  • Netherlands
  • 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 NCT01164592 on ClinicalTrials.gov