Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure (Major Substudy of SERVE-HF)

Phase 4

Completed

Conditions: sleep disordered breathing, predominantly central sleep apnea syndrome
central sleep apnea
heart failure
10019280

Registration Number: NL-OMON37747

Lead Sponsor: Europe ResMed Germany Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

The inclusion criteria for the parent SERVE-HF Study apply to the sub-study:
• Patient must be at least 22 years old
• Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines
• LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cMRI documented less than 12 weeks before randomization
• NYHA Class III or IV at the time of inclusion or NYHA Class II with at least one hospitalization for heart failure 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, with no new class of disease modifying drug for more than 4 weeks prior to randomization. In case of no beta blockers or ACE inhibitors/ARB antagonists the reasons must be documented.
• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from polygraphy or polysomnography (based on total recording time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula.
• Patient is able to understand fully the study information and to provide signed informed consent
Additional inclusion criteria for the substudy
• Patients must be at least 22 years old
• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula

Exclusion Criteria

Patient Exclusion Criteria of the Parent Study
Patients will not fulfil any of the parent SERVE-HF Study exclusion criteria:
• Significant chronic obstructive pulmonary disease with forced expiratory volume within one second < 50% of age and gender normal values, in the last 4 weeks before randomization
• Oxygen saturation at rest during the day <= 90% at inclusion
• Current use of positive airways pressure
• Life expectancy < 1 year for disease unrelated to chronic heart failure
• Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within 6 months prior to randomization
• CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months prior to randomization
• Transient ischaemic attack or stroke within 3 months prior to randomization
• Primary haemodynamically 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 randomization
• Untreated or therapy refractory Restless Leg Syndrome
• 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
Additional exclusion criteria for the substudy
• Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
• Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomization

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in LV ejection fraction (EF), as measured by<br /><br>Echocardiography, from baseline to 12 months comparing patients randomised to<br /><br>ASV (in addition to optimal medical therapy) with those randomised to continue<br /><br>with optimal medical therapy alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Changes in left and right ventricular function<br /><br>• Changes in LV systolic and diastolic indexed volumes<br /><br>• Changes in right ventricular (RV) systolic and diastolic indexed volumes<br /><br>• Changes in LV and RV mass<br /><br>• Changes in LV sphericity index and LV end-systolic global wall stress<br /><br>• Changes in sleep duration and sleep stages as well as arousals<br /><br>• Changes in sleep-disordered breathing<br /><br>• Changes in quality of life assessed by Kansas City Cardiomyopathy<br /><br>Questionnaire (KCCQ)<br /><br>• Changes in mental status assessed by Mini-Mental State Examination (MMSE)<br /><br>• Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety<br /><br>Questionnaire GAD-7</p><br>