Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
- Conditions
- Cheyne Stokes RespirationHeart FailureSleep Disorder
- Interventions
- Device: adaptive servoventilation (ASV)
- 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
- Arm && Interventions
Group Intervention Description Therapy with adaptive servo ventilation adaptive servoventilation (ASV) optimal medical therapy + adaptive servoventilation
- 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
CardioVaskuläres Centrum Frankfurt
🇩🇪Frankfurt, Germany
Kath. Kliniken Essen/ Philippusstift
🇩🇪Essen, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Praxis für Kardiologie Dr. med. Menz
🇩🇪Menden, Germany
Klinikum Augustinum München
🇩🇪München, Germany
Evangelisches Krankenhaus Mülheim
🇩🇪Mülheim an der Ruhr, Germany
Kardiologische Praxis Nienburg
🇩🇪Nienburg, Germany
Städtisches Khs Lukas
🇩🇪Neuss, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Melbourne Sleep Disorders Centre
🇦🇺East Melbourne, Victoria, Australia
St. Anne's University Hospital
🇨🇿Brno, Czech Republic
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
POLIKUM Friedenau
🇩🇪Berlin, Germany
Praxis Dr. Hecker
🇩🇪Dortmund, Germany
Praxis Dr. Lodde
🇩🇪Dortmund, Germany
Praxis Dr. Diedrichs
🇩🇪Frechen, Germany
Praxis Dr. Hein
🇩🇪Reinbek, Germany
Katharinen Hospital Unna
🇩🇪Unna, Germany
Rivercity Private Hospital
🇦🇺Auchenflower, Queensland, Australia
St. Vincents and Mercy Private Hospital
🇦🇺Melbourne, Victoria, Australia
DRK Krankenhaus
🇩🇪Alzey, Germany
Hollywood Private Hospital (CVS)
🇦🇺Nedlands, Western Australia, Australia
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Unesta Research Centre
🇫🇮Tampere, Finland
Clinique Mutualiste des Eaux Claires
🇫🇷Grenoble, France
CHU Grenoble, Hopital Michallon
🇫🇷Grenoble, France
CHU de Poitiers
🇫🇷Poitiers, France
Herzzentrum Bad Krozingen
🇩🇪Bad Krozingen, Germany
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
Charité Campus Mitte CCM
🇩🇪Berlin, Germany
Helsinki University Hospital
🇫🇮Helsinki, Finland
Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
🇫🇮Tampere, Finland
Kardiologie Praxis Dr. Bonnekamp
🇩🇪Essen, Germany
Kardiologische Praxis Dr. Isbruch
🇩🇪Castrop-Rauxel, Germany
Khs Florence-Nightingale
🇩🇪Duesseldorf, Germany
Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Germany
Herzzentrum Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg im Breisgau, Germany
Kardiologische Praxis Gütersloh
🇩🇪Gütersloh, Germany
B&B GmbH
🇩🇪Herne, Germany
Cardio-Praxis Herne Dr. Furche
🇩🇪Herne, Germany
Gemeinschaftspraxis Dres. Guckenbiehl
🇩🇪Flonheim, Germany
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Gemeinschaftspraxis Dres Leischik/Littwitz
🇩🇪Hagen, Germany
Lungenklinik Hemer
🇩🇪Hemer, Germany
Kardiologische Praxis Dr. Schlichting
🇩🇪Herne, Germany
Cardiopraxis Ingelheim
🇩🇪Ingelheim, Germany
Krankenhaus Bethanien
🇩🇪Moers, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor
🇩🇪Lübeck, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Missionsärztliche Klinik Würzburg
🇩🇪Wuerzburg, Germany
Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck
🇩🇪Wiesbaden, Germany
Praxis Dr. Gerritsen
🇩🇪Waldkraiburg, Germany
Kardiologisch angiologische Gemeinschaftspraxis
🇩🇪Wiesbaden, Germany
Ospedale Regionale di Lugano
🇨🇭Lugano, Switzerland
Brompton Hospital
🇬🇧London, United Kingdom
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Ruhrlandklinik Essen
🇩🇪Essen, Germany
Praxis Dr. Tekiyeh
🇩🇪Essen, Germany
Jüdisches Krankenhaus Berlin
🇩🇪Berlin, Germany
Kardiologische Praxis Marschner
🇩🇪Bonn, Germany
Helios Klinikum Borna
🇩🇪Borna, Germany
Praxis für Lunge Herz und Schlaf
🇩🇪Bielefeld, Germany
Kardiologie Brühl
🇩🇪Brühl, Germany
Gemeinschaftspraxis Kardiologie Dr. Becker
🇩🇪Castrop-Rauxel, Germany
Kardiologie Oberkassel
🇩🇪Düsseldorf, Germany
Gemeinschaftspraxis PD Dr. Lankisch
🇩🇪Düsseldorf, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Gemeinschaftspraxis Dr. Bruch
🇩🇪Herne, Germany
Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet
🇩🇪Herne, Germany
Praxis Dr. Anselm Bäumer
🇩🇪Köln, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
🇩🇪Lübeck, Germany
Kardiologische Praxis Dr. Schön
🇩🇪Mühldorf, Germany
Lungenärzte am Rotkreuzplatz
🇩🇪München, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Praxis Dr. Fröhlich
🇩🇪Ratingen, Germany
Khs St. Adolf Stift
🇩🇪Reinbek, Germany
Kardiologische Praxis Dr. Wetzel
🇩🇪Dortmund, Germany
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
🇩🇪Köln, Germany
Universität Leipzig -Herzzentrum
🇩🇪Leipzig, Germany
St. Elisabeth-Hospital Herten gGmbH
🇩🇪Herten, Germany
Gemeinschaftpraxis Dres. Schmidt/Gronke
🇩🇪Dresden, Germany
Praxis Dr. Hohensee
🇩🇪Dresden, Germany
Malteser Krankenhaus St. Hildegardis
🇩🇪Köln, Germany
Klinikum der Universität zu Köln- Herzzentrum
🇩🇪Köln, Germany
Gemeinschaftspraxis Dres. Dobler/Turin
🇩🇪Karlstadt, Germany
Comprehensive Heart Failure Center, Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Klinikum der Universität zu Köln-Schlaflabor
🇩🇪Köln, Germany
Charité Campus Mitte
🇩🇪Berlin, Germany