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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo).
Time frame: Baseline (Randomization), 6- and 12 month-Follow-up-visit
Changes in left and right ventricular function
Time frame: Baseline (Randomization), 6-and 12-month-Follow-up visit
Changes in LV systolic and diastolic indexed volumes
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in right ventricular (RV) systolic and diastolic indexed volumes
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in LV and RV mass
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in LV sphericity index and LV end-systolic global wall stress
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in sleep duration and sleep stages as well as arousals
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in sleep-disordered breathing
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in mental status assessed by Mini-Mental State Examination (MMSE)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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, Czechia
Helsinki University Hospital
Helsinki, Finland
Unesta Research Centre
Tampere, Finland
Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
Tampere, Finland
...and 84 more locations
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit
Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7
Time frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit