Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure

Phase 4

Completed

Conditions: sleep disordered breathing
central sleep apnea
heart failure
10019280

Registration Number: NL-OMON41427

Lead Sponsor: ResMed Ltd., Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• 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 hospitalization for HF in the last 24 months
• No hospitalization for heart failure for at least 4 weeks prior to inclusion
• Optimised medical treatment according to applicable guidelines (see Appendix X) with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
• SDB (AHI > 15 events/hour with >= 50% central events and a central AHI >= 10 events/hour, 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
• Patient is able to fully understand study information and signed informed consent

Exclusion Criteria

• Significant COPD 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-implantation (either CRT-D or CRT-P) 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
• Patients for whom the use of AutoSet CS / S9 VPAP Adapt may be contra-indicated according to
the user*s manual of the device used
• Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to first event of:<br /><br>1) all cause mortality or unplanned hospitalization / prolongation of<br /><br>hospitalization for worsening heart failure<br /><br>2) cardiovascular mortality or unplanned hospitalization / prolongation of<br /><br>hospitalization for worsening heart failure.<br /><br>3) all cause mortality or all cause unplanned hospitalization / prolongation of<br /><br>hospitalization<br /><br><br /><br>Heart transplantation, appropriate shock from ICD, long term assist device<br /><br>(LTAD) insertion and survived resuscitation of sudden cardiac arrest are<br /><br>counted as cardiovascular death, survived resuscitation for other reasons is<br /><br>counted as all cause death.<br /><br><br /><br>The three combinations are not tested in parallel but in this hierarchical<br /><br>order.</p><br>

Secondary Outcome Measures