Status:
COMPLETED
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
Lead Sponsor:
ResMed
Collaborating Sponsors:
CRI-The Clinical Research Institute GmbH
Conditions:
Heart Failure
Sleep Disordered Breathing
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 le...
Detailed Description
Objective: 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 failur...
Eligibility Criteria
Inclusion
- Patients must be at least 22 years old
- Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
- Left ventricular systolic dysfunction (LVEF ≤45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
- NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
- No hospitalisation for heart failure for at least 4 weeks prior to inclusion
- Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) antagonists the reasons must be documented
- SDB (AHI \> 15/h with ≥ 50% central events and a central AHI ≥ 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
- Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
- Patient is able to fully understand study information and signed informed consent
Exclusion
- Significant COPD (chronic obstructive pulmonary disease) with Forced Expiratory Volume within one second (FEV1) \<50% (European Respiratory Society criteria) in the last four weeks before randomisation
- Oxygen saturation at rest during the day ≤ 90% at inclusion
- Current use of Positive Airway Pressure (PAP) - therapy
- Life expectancy \< 1 year for diseases unrelated to chronic HF
- Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
- CRT (cardiac resynchronisation therapy)-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
- Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
- Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
- Acute myocarditis/pericarditis within 6 months prior to randomisation
- Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
- Pregnancy
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1325 Patients enrolled
Trial Details
Trial ID
NCT00733343
Start Date
February 1 2008
End Date
June 1 2015
Last Update
May 12 2020
Active Locations (267)
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1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
2
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
St Vincents and Mercy Private Hospital
Melbourne, Victoria, Australia, 3065