Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
- Conditions
- Cheyne Stokes RespirationHeart FailureSleep Disorder
- Registration Number
- NCT01164592
- Lead Sponsor
- ResMed
- Brief 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.
- Detailed Description
This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.
For the purpose of this substudy, patients will be followed up for a period of 12 months.
The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:
* Echocardiogram (for both groups)
* cMRI (for both groups)
* PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
* 4 questionnaires (for both groups)
* Additional blood testing (for both groups)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 312
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo). Baseline (Randomization), 6- and 12 month-Follow-up-visit
- Secondary Outcome Measures
Name Time Method Changes in sleep-disordered breathing Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in left and right ventricular function Baseline (Randomization), 6-and 12-month-Follow-up visit Changes in LV systolic and diastolic indexed volumes Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in right ventricular (RV) systolic and diastolic indexed volumes Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in LV and RV mass Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in LV sphericity index and LV end-systolic global wall stress Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in sleep duration and sleep stages as well as arousals Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in mental status assessed by Mini-Mental State Examination (MMSE) Baseline (Randomization), 6- and 12-month-Follow-up-visit Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7 Baseline (Randomization), 6- and 12-month-Follow-up-visit
Trial Locations
- Locations (94)
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Rivercity Private Hospital
🇦🇺Auchenflower, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Melbourne Sleep Disorders Centre
🇦🇺East Melbourne, Victoria, Australia
St. Vincents and Mercy Private Hospital
🇦🇺Melbourne, Victoria, Australia
Hollywood Private Hospital (CVS)
🇦🇺Nedlands, Western Australia, Australia
St. Anne's University Hospital
🇨🇿Brno, Czech Republic
Helsinki University Hospital
🇫🇮Helsinki, Finland
Unesta Research Centre
🇫🇮Tampere, Finland
Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
🇫🇮Tampere, Finland
Scroll for more (84 remaining)Westmead Hospital🇦🇺Westmead, New South Wales, Australia