Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

NCT ID: NCT01164592

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

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)

Conditions

Heart Failure; Sleep Disorder; Cheyne Stokes Respiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapy with adaptive servo ventilation

optimal medical therapy + adaptive servoventilation

Group Type: ACTIVE_COMPARATOR

adaptive servoventilation (ASV)

Intervention Type: DEVICE

Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours

Optimal medical therapy according to guidelines

optimal medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

adaptive servoventilation (ASV)

Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours

Intervention Type: DEVICE

Other Intervention Names

Adaptive Servo-Ventilation with AutoSet CS

Eligibility Criteria

Inclusion Criteria

• Over 22 years of age
• Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
• Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
• Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
• Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
• Optimised medical treatment according to the applicable guidelines
• Able to provide informed consent

• 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 have to be performed with nasal cannula

Exclusion Criteria

• Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
• Oxygen saturation at rest during the day 90% at the time of inclusion
• Current use of Positive Airway Pressure (PAP) therapy
• Life expectancy < 1 year for diseases unrelated to chronic heart failure
• Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
• Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
• Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
• Primary hemodynamically 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 randomisation
• Untreated or therapy refractory Restless legs Syndrome (RLS)
• Pregnancy

• Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
• Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Cowie, Prof

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton Hospital, London

Holger Woehrle, MD

Role: STUDY_DIRECTOR

ResMed

Locations

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

Clinique Mutualiste des Eaux Claires

Grenoble, , France

CHU Grenoble, Hopital Michallon

Grenoble, , France

CHU de Poitiers

Poitiers, , France

Universitätsklinikum Aachen

Aachen, , Germany

DRK Krankenhaus

Alzey, , Germany

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Charité Campus Mitte CCM

Berlin, , Germany

Charité Campus Mitte

Berlin, , Germany

POLIKUM Friedenau

Berlin, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Praxis für Lunge Herz und Schlaf

Bielefeld, , Germany

Kardiologische Praxis Marschner

Bonn, , Germany

Helios Klinikum Borna

Borna, , Germany

Kardiologie Brühl

Brühl, , Germany

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, , Germany

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, , Germany

Malteser Krankenhaus St. Hildegardis

Cologne, , Germany

Klinikum der Universität zu Köln- Herzzentrum

Cologne, , Germany

Klinikum der Universität zu Köln-Schlaflabor

Cologne, , Germany

Praxis Dr. Anselm Bäumer

Cologne, , Germany

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, , Germany

Praxis Dr. Hecker

Dortmund, , Germany

Kardiologische Praxis Dr. Wetzel

Dortmund, , Germany

Praxis Dr. Lodde

Dortmund, , Germany

Facharztzentrum Dresden-Neustadt GbR

Dresden, , Germany

Gemeinschaftpraxis Dres. Schmidt/Gronke

Dresden, , Germany

Praxis Dr. Hohensee

Dresden, , Germany

Herzzentrum Universität Dresden

Dresden, , Germany

Khs Florence-Nightingale

Düsseldorf, , Germany

Kardiologie Oberkassel

Düsseldorf, , Germany

Gemeinschaftspraxis PD Dr. Lankisch

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Kardiologie Praxis Dr. Bonnekamp

Essen, , Germany

Praxis Dr. Tekiyeh

Essen, , Germany

Ruhrlandklinik Essen

Essen, , Germany

Kath. Kliniken Essen/ Philippusstift

Essen, , Germany

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, , Germany

CardioVaskuläres Centrum Frankfurt

Frankfurt, , Germany

Praxis Dr. Diedrichs

Frechen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Kardiologische Praxis Gütersloh

Gütersloh, , Germany

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, , Germany

Lungenklinik Hemer

Hemer, , Germany

B&B GmbH

Herne, , Germany

Cardio-Praxis Herne Dr. Furche

Herne, , Germany

Gemeinschaftspraxis Dr. Bruch

Herne, , Germany

Kardiologische Praxis Dr. Schlichting

Herne, , Germany

Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

Herne, , Germany

St. Elisabeth-Hospital Herten gGmbH

Herten, , Germany

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Cardiopraxis Ingelheim

Ingelheim, , Germany

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, , Germany

Universität Leipzig -Herzzentrum

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

Lübeck, , Germany

Praxis für Kardiologie Dr. med. Menz

Menden, , Germany

Krankenhaus Bethanien

Moers, , Germany

Kardiologische Praxis Dr. Schön

Mühldorf, , Germany

Evangelisches Krankenhaus Mülheim

Mülheim, , Germany

Lungenärzte am Rotkreuzplatz

München, , Germany

Klinikum Augustinum München

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

Städtisches Khs Lukas

Neuss, , Germany

Kardiologische Praxis Nienburg

Nienburg, , Germany

Praxis Dr. Fröhlich

Ratingen, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Khs St. Adolf Stift

Reinbek, , Germany

Praxis Dr. Hein

Reinbek, , Germany

Katharinen Hospital Unna

Unna, , Germany

Praxis Dr. Gerritsen

Waldkraiburg, , Germany

Kardiologisch angiologische Gemeinschaftspraxis

Wiesbaden, , Germany

Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

Wiesbaden, , Germany

Missionsärztliche Klinik Würzburg

Würzburg, , Germany

Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

Würzburg, , Germany

University Medical Center Groningen

Groningen, , Netherlands

Cardiocentro Ticino

Lugano, , Switzerland

Ospedale Regionale di Lugano

Lugano, , Switzerland

Brompton Hospital

London, London, United Kingdom

Countries

Australia; Czechia; Finland; France; Germany; Netherlands; Switzerland; United Kingdom

Other Identifiers

01a

Identifier Type: -

Identifier Source: org_study_id