Cheyne Stokes Respiration, Heart Failure, Sleep Disorder
Conditions
Keywords
Heart failure (HF), Sleep disordered breathing (SDB), Cheyne Stokes Respiration (CSR), Adaptive Servoventilation (ASV)
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)
Interventions
DEVICEadaptive servoventilation (ASV)
Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion and
Exclusion criteria
are mainly those applicable for the parent study; SERVE-HF. The inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 sleep-disordered breathing | 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 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 |
| 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 quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline (Randomization), 6- and 12-month-Follow-up-visit |
Countries
Australia, Czechia, Finland, France, Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed