AzTrials
AzTrials

Heart FailureServe-HFNCT00733343

Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure

A study testing Europe: AutoSet CS (USA: VPAP Adapt SV) in people with Heart Failure and Sleep Disordered Breathing, run by ResMed at 267 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing… Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Heart Failure, Sleep Disordered Breathing
What is being tested?
Europe: AutoSet CS (USA: VPAP Adapt SV)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,325 participants
Where
267 sitesin 11 countries
Study dates
Feb 2008to Jun 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be at least 22 years old
  • Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
  • Left ventricular systolic dysfunction (LVEF ≤45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
  • NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
  • No hospitalisation for heart failure for at least 4 weeks prior to inclusion
  • Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) antagonists the reasons must be documented
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  • SDB (AHI > 15/h with ≥ 50% central events and a central AHI ≥ 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
  • Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
  • Patient is able to fully understand study information and signed informed consent

Who cannot join

  • Significant COPD (chronic obstructive pulmonary disease) with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
  • Oxygen saturation at rest during the day ≤ 90% at inclusion
  • Current use of Positive Airway Pressure (PAP) - therapy
  • Life expectancy < 1 year for diseases unrelated to chronic HF
  • Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
  • CRT (cardiac resynchronisation therapy)-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
Show all 11Show fewer
  • 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) according to criteria listed in Appendix IX at the time of study entry
  • Pregnancy

Trial locations and contacts

267 sites in 11 countries.

267 sites in 11 countries

Germany185 sites

  • Praxis Dr. Frieske

    Aachen, 52062

  • Universitätsklinikum Aachen

    Aachen, 52074

  • DRK Krankenhaus

    Alzey, 55232

  • Gemeinschaftspraxis Weiß / Dr. Heesing

    Arnsberg, 59821

  • Zentralklinikum Bad Berka

    Bad Berka, 99437

  • Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Klinik Lazariterhof

    Bad Krozingen, 79189

  • Schlaflabor Breisgau

    Bad Krozingen, 79189

  • Praxis Dr. Bauer

    Bad Mergentheim, 97980

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545

  • Oberlausitz-Kliniken gGmbH

    Bautzen, 02625

  • Kardiologie Brühl

    Bergheim, 50126

  • Kardiopraxis Rheinberg

    Bergisch Gladbach, 51465

  • Charité Campus Mitte - Kardiologie

    Berlin, 10117

  • Charité Campus Mitte CCM- Schlafmedizinisches Zentrum

    Berlin, 10117

  • POLIKUM Friedenau

    Berlin, 12157

  • Gemeinschaftspraxis Groß-Ziethener Chaussee

    Berlin, 12355

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Evangelische Lungenfachklinik Buch

    Berlin, 13125

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • Praxis Westend

    Berlin, 14050

  • Herzzentrum Brandenburg

    Bernau, 16321

  • Praxis für Lunge, Herz und Schlaf

    Bielefeld, 33617

  • Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

    Bochum, 44787

  • Universitätsklinikum Bergmannsheil

    Bochum, 44789

  • Augusta Krankenanstalten Bochum

    Bochum, 44791

  • St.-Josephs-Hospital

    Bochum, 44791

  • Kardiologie Kemnade

    Bochum, 44797

  • Kardiologische Praxis Dr. Staubach

    Bochum, 44866

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Kardiologische Praxis Marschner

    Bonn, 53225

  • Helios Klinikum Borna

    Borna, 04552

  • Gemeinschaftspraxis Kardiologie

    Bottrop, 46236

  • Klinikum Bremen Ost

    Bremen, 28325

  • Kardiologie Brühl

    Brühl, 50321

  • Mediclin Rehazentrum Spreewald

    Burg, 03096

  • Gemeinschaftspraxis Kardiologie Dr. Becker

    Castrop-Rauxel, 44575

  • Kardiologische Praxis Dr. Isbruch

    Castrop-Rauxel, 44577

  • MVZ am Küchwald

    Chemnitz, 09113

  • Klinikum Coburg GmbH

    Coburg, 96450

  • St.-Vinzenz Hospital

    Cologne, 50733

  • Kardiologische Praxis Dr. Fritsch

    Cologne, 50737

  • Malteser Krankenhaus St.Hildegardis

    Cologne, 50931

  • Prof. Franzen Institut

    Cologne, 50937

  • Praxis Dr. Anselm Bäumer

    Cologne, 51065

  • Gemeinschaftspraxis Dres. Gysan/Heinzler/May

    Cologne, 51105

  • Fachkrankenhaus Coswig

    Coswig, 01640

  • Carl-Thiem-Klinikum gGmbH

    Cottbus, 03042

  • Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

    Cottbus, 03050

  • MECS Cottbus GmbH

    Cottbus, 03050

  • Praxis Dr. Hecker

    Dortmund, 44135

  • Kardiologische Praxis Dr. Golling

    Dortmund, 44137

  • Clinical Trial Site Services

    Dortmund, 44141

  • Kardiologische Praxis Dr. Wetzel

    Dortmund, 44141

  • Kardiologische Praxis Dr. Lodde

    Dortmund, 44147

  • Kardiologische Praxis Dr. Dröse

    Dortmund, 44263

  • Facharztzentrum Dresden-Neustadt GbR

    Dresden, 01099

  • Gemeinschaftspraxis Dres. Schmidt/Gronke

    Dresden, 01219

  • Praxis Dr. Hohensee

    Dresden, 01277

  • Herzzentrum Universität Dresden

    Dresden, 01307

  • goMedus Gesundheitszentrum

    Düsseldorf, 40212

  • Kardiologische Praxis Dr. Horowitz

    Düsseldorf, 40215

  • Evangelisches Krankenhaus

    Düsseldorf, 40217

  • Kardiologische Praxis Dr. Raff

    Düsseldorf, 40237

  • Florence-Nightingale Krankenhaus

    Düsseldorf, 40489

  • Kardiologie Oberkassel

    Düsseldorf, 40545

  • Gemeinschaftspraxis PD. Dr. Lankisch

    Düsseldorf, 40597

  • Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl

    Emmendingen, 79312

  • Helios Klinikum Erfurt-Kardiologie

    Erfurt, 99089

  • Helios Klinikum Erfurt-Schlafmedizin

    Erfurt, 99089

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Westdeutsches Herzzentrum, Universitätsklinikum Essen

    Essen, 45122

  • Kardiologische Praxis Dr. Cord Müller

    Essen, 45131

  • Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

    Essen, 45131

  • Kardiologische Praxis Prof. Winter

    Essen, 45134

  • Kardiologie Praxis Dr. Bonnekamp

    Essen, 45136

  • Praxis Dr. Tekiyeh

    Essen, 45136

  • Elisabeth-Krankenhaus Essen

    Essen, 45138

  • Ruhrlandklinik Essen

    Essen, 45239

  • Praxis Dr. Rau

    Essen, 45276

  • Kath. Kliniken Essen / Philippusstift

    Essen, 45359

  • Gemeinschaftspraxis Dres. Guckenbiehl

    Flonheim, 55237

  • Kardiologische Praxis Dr. Kruse

    Forst, 03149

  • CardioVasculäres Centrum Frankfurt

    Frankfurt, 60389

  • Praxis Dr. Diedrichs

    Frechen, 50226

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Gemeinschaftspraxis Dres. Böhmeke/Schmidt

    Gladbeck, 45964

  • Kardiologische Praxis Dr. Hug

    Günzburg, 89312

  • Kardiologische Praxis Gütersloh

    Gütersloh, 33334

  • Gemeinschaftspraxis Dres Leischik/Littwitz

    Hagen, 58095

  • Kardiologische Praxis Dr. Arens

    Hagen, 58095

  • Gemeinschaftspraxis Dres. Subin/Lutter

    Hamburg, 20095

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Internistenpraxis Alstertal Hamburg

    Hamburg, 22399

  • Kardiologische Praxis Dr. Cierpka

    Hanover, 30159

  • Praxis Dr. Hötte

    Hanover, 30449

  • Siloah Krankenhaus

    Hanover, 30449

  • Kardiologische Praxis Dr. Hartung

    Hanover, 30559

  • MH Hannover

    Hanover, 30625

  • Klinikum Hannover Oststadt-Heidehaus

    Hanover, 30659

  • Praxis Dr. Durak

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Kardiologische Praxis Dr. Furche

    Herne, 44623

  • Gemeinschaftspraxis Dr. Bruch

    Herne, 44629

  • Kardiologische Praxis Dr. Schlichting

    Herne, 44649

  • Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

    Herne, 44651

  • St. Elisabeth-Hospital Herten gGmbH

    Herten, 45699

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Cardiopraxis Ingelheim

    Ingelheim, Rhineland-Palatinate, 55218

  • Gemeinschaftspraxis Dres. Dobler/Turin

    Karlstadt am Main, 97753

  • Ambulantes Herzzentrum Kassel

    Kassel, 34121

  • Kardiologische Praxis Dr. Siegfried Frickel

    Kempen, 47906

  • Klinikum Dahme-Spreewald GmbH

    Königs Wusterhausen, 15711

  • Praxis Dr. Krater

    Krefeld, 47799

  • Helios Klinikum Krefeld

    Krefeld, 47805

  • Universitätsklinikum Leipzig-Herzzentrum

    Leipzig, 04289

  • Helios Krankenhaus Leisnig

    Leisnig, 04703

  • Gemeinschaftspraxis Dr. Hilgedieck/Sava

    Lengerich, 49525

  • Kardiologische Praxis Dr. Faber

    Lindlar, 51784

  • Ärztezentrum Holthausen-Biene

    Lingen, 49808

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

    Lübeck, 23538

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

    Lübeck, 23538

  • Klinikum der Johannes Gutenberg-Universität Mainz

    Mainz, 55101

  • Cardiopraxis Ingelheim

    Mainz, 55116

  • Universitätsklinikum Mannheim-Schlafmedizin

    Mannheim, 68135

  • Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

    Mannheim, 68161

  • Gemeinschaftspraxis für Herz & Gefäße

    Mannheim, 68161

  • Universitätsklinik Mannheim-Kardiologie

    Mannheim, 68167

  • Gemeinschaftspraxis Dres. Brandt / Jakobs

    Mannheim, 68305

  • Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

    Marburg, 35033

  • Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

    Marburg, 35043

  • Praxis Dr. Schnabel

    Meissen, 01662

  • Gemeinschaftspraxis Dr. Jocham

    Memmingen, 87700

  • Praxis Für Kardiologie Dr. med. Menz

    Menden, 58706

  • Krankenhaus Bethanien

    Moers, 47441

  • Kardiologische Praxis Dr. Schön

    Mühldorf, 84453

  • Evangelisches Krankenhaus Mülheim

    Mülheim, 45468

  • Kardiologie am Rotkreuzplatz

    München, 80634

  • Lungenärzte am Rotkreuzplatz

    München, 80634

  • Gemeinschaftspraxis Dres. Wauer / Windstetter

    München, 80799

  • Kardiologische Praxis Dr. Herholz

    München, 80809

  • Klinik Augustinum München

    München, 81375

  • Praxis Dres. Böhme/Linke

    München, 81667

  • Kardiologische Praxis Dr. Muradi

    Münster, 29633

  • Universitätsklinikum Münster

    Münster, 48149

  • Praxis für Kardiologie Dr. med. Hewing

    Münster, 48151

  • Lukaskrankenhaus GmbH

    Neuss, 41464

  • Kardiologische Praxis Nienburg

    Nienburg, 31582

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Klinikum Nürnberg Süd

    Nuremberg, 90471

  • Kardiologische Praxis Dr. Gumbrecht

    Ochtrup, 48607

  • Kardiologische Praxis Dr. Wiethölter

    Radebeul, 01445

  • Praxis für Kardiologie Ratingen

    Ratingen, 40878

  • Praxis Dr. Fröhlich

    Ratingen, 40885

  • DRK Krankenhaus Mölln-Ratzeburg

    Ratzeburg, 23909

  • Ambulantes Cardiovaskuläres Centrum

    Ravensburg, 88212

  • Gemeinschaftspraxis Dr. Weber/Dr. Feja

    Recklinghausen, 45657

  • Knappschafts-Krankenhaus Recklinghausen

    Recklinghausen, 45657

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek, 21465

  • Praxis Dr. Hein

    Reinbek, 21465

  • Praxis Dr. Nebel

    Rheine, 48429

  • Praxis Dr. Kestermann

    Rheine, 48431

  • Praxis Dr. Ebeling

    Schönefeld, 12529

  • Kardiologische Praxis Dr. Heinze

    Schwerte, 58239

  • Praxisgemeinschaft Cardio-Soest

    Soest, 59494

  • Facharztzentrum Sonneberg

    Sonneberg, 96515

  • Kreiskrankenhaus Stollberg GmbH

    Stollberg, 09366

  • Klinikum Uelzen GmbH

    Uelzen, 29525

  • Herzklinik Ulm Dr. Haerer und Partner

    Ulm, 89077

  • Zentrum für Innere Medizin Uni Ulm

    Ulm, 89081

  • Katharinen Hospital Unna

    Unna, 59423

  • Kardiologische Praxis Dr. Burkhard-Meier

    Viersen, 41747

  • Praxis Dr. Gerritsen

    Waldkraiburg, 84478

  • Fachkliniken Wangen

    Wangen, 88239

  • Stiftungsklinik Weißenhorn

    Weißenhorn, 89264

  • Kardiologische Praxis Dr. Vrettos

    Witten, 58452

  • Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

    Worms, 67547

  • Missionsärztliche Klinik Würzburg

    Würzburg, 97074

  • Universitätsklinikum Würzburg

    Würzburg, 97080

  • Evangel. Khs Zweibrücken

    Zweibrücken, 66482

Other trials in Germany

France49 sites

  • Cardiologist Dr. Papola

    Amnéville, 57360

  • CHU Angers

    Angers, 49933

  • Centre Hospitalier d'Antibes Juan-les-Pins

    Antibes, 06606

  • Hopital Prive d'Antony

    Antony, 92166

  • CH Belfort

    Belfort, 90000

  • CH de Besancon

    Besançon, 25000

  • Centre Hospitalier de Béziers

    Béziers, 34525

  • Clinique du Tondu

    Bordeaux, 33000

  • Hôpital St. André

    Bordeaux, 33000

  • Praxis Cardiologique Dr. Puel

    Bordeaux, 33000

  • Praxis Cardiologique Dr. Wickers

    Bordeaux, 33000

  • CHU Bordeaux, Hopital Pellegrin

    Bordeaux, 33076

  • CHU de Caen

    Caen, 14033

  • Centre Hospitalier de Cannes

    Cannes, 06401

  • Hopital Henri Mondor

    Créteil, 94010

  • Hôpital Sud

    Échirolles, 38434

  • CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

    Forbach, 57604

  • CH de Forbach-Cardiology

    Forbach, 57604

  • Clinique Mutualiste des Eaux Claires

    Grenoble, 38000

  • CHU Grenoble, Hopital Michallon

    Grenoble, 38043

  • CH Haguenau

    Haguenau, 67504

  • Clinique de L'Union

    L'Union, 31240

  • CHU Lille- Hopital Cardiologique

    Lille, 59037

  • CHU Lille-Sleep medicine

    Lille, 59037

  • Polyclinique La Louviere

    Lille, 59042

  • Hospices Civils de Lyon, Hopital de la Croix-Rousse

    Lyon, 69317

  • CHR Metz, Hôpital de Bon-Secours

    Metz, 57000

  • CH Montbeliard

    Montbéliard, 25209

  • CHU de Montpellier

    Montpellier, 34295

  • CH Intercommunal André Grégoire

    Montreuil, 93105

  • CH de Mulhouse, Hopital Emile Muller

    Mulhouse, 68070

  • Clinique les Fleurs

    Ollioules, 83190

  • Hôpital Bichat

    Paris, 75018

  • CHU Tenon

    Paris, 75790

  • CHU de Bordeaux, Hopital Haut Leveque

    Pessac, 33600

  • CHU de Poitiers

    Poitiers, 86000

  • Cabinet de cardiologie

    Pont-à-Mousson, 54700

  • CH Rene Dubos

    Pontoise, 95303

  • Polyclinique Saint-Laurent

    Rennes, 35706

  • CHU de Rouen, Hopital de Bois Guillaume

    Rouen, 76031

  • CH Lemire - St Avold

    Saint-Avold, BP 30011

  • CH de St Dié des Vosges

    Saint-Dié, 88187

  • CHU de Saint-Etienne, Hopital Nord

    Saint-Etienne, 42055

  • Clinique des Trois Frontières

    Saint-Louis, 68300

  • CHU Toulouse, Hopital de Rangueil

    Toulouse, 31059

  • CHU Toulouse, Hopital Larrey

    Toulouse, 31059

  • CH Trouville

    Trouville, 14360

  • CHU de Nancy, Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

  • Ch St. Nicolas

    Verdun, 55100

Other trials in France

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Rivercity Private Hospital

    Auchenflower, Queensland, 4066

  • Melbourne Sleep Disorders Centre

    East Melbourne, Victoria 3002, 3002

  • St Vincents and Mercy Private Hospital

    Melbourne, Victoria, 3065

  • Hollywood Private Hospital (CVS)

    Nedlands, Western Australia, 6009

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Denmark6 sites

  • Århus Universitets Hospital

    Århus C, 8000

  • Århus Universitets Hospital Skejby

    Århus N, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Bispebjerg Hospital

    Copenhagen, 2400

  • Dansk Center For Søvnmedicin

    Glostrup Municipality, 2600

  • Glostrup Hospital

    Glostrup Municipality, 2600

Other trials in Denmark

United Kingdom6 sites

  • Chesterfield Royal Hospital

    Chesterfield, Calow S44 5DX

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU165JQ

  • Brompton Hospital

    London, SW36NP

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Musgrove Park Hospital

    Taunton, TA1 5DA

  • Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Sweden5 sites

  • Sahlgrenska University Hospital / Östra

    Gothenburg, 41345

  • Sahlgrenska University Hospital / Östra

    Gothenburg, U/6 85

  • Specialistläkarmottagning Residenset AB

    Jönköping, 55316

  • Skaraborgs Hospital

    Lidköping, 53185

  • Linköping University Hospital

    Linköping, 58185

Other trials in Sweden

Finland3 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Unesta Research Centre

    Tampere, 33520

  • Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

    Tampere, 33521

Other trials in Finland

Norway3 sites

  • Ullevål University Hospital

    Oslo, 0407

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0424

  • Stavanger AS

    Stavanger, 4011

Other trials in Norway

Switzerland2 sites

  • Cardiocentro Ticino

    Lugano, 6900

  • Ospedale Regionale di Lugano

    Lugano, 6903

Other trials in Switzerland

Czechia1 site

  • St. Anne's University Hospital BRNO

    Brno, 65691

Other trials in Czechia

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700

Other trials in Netherlands

About this study

Official title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

Read the detailed description

Objective: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea.

Study Design: Randomized, multicentre, international trial with parallel group design, with patients randomized to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. There will be no sham-positive airway pressure treatment in the control arm. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time. The trial is an event driven design: the final analysis is to be performed latest when 651 events have been observed. The primary analysis is in the intention-to-treat population that consists of all patients randomized.

Number of Patients: 1116 patients will be randomly assigned to one of the two treatment groups. A 20% drop out rate is estimated.

Selection criteria: Patients at the age of or over 22 years with severe chronic heart failure (chronic HF), New York Heart Association (NYHA) class III-IV or NYHA class II with at least one hospitalization for HF within the last 24 months, with Left Ventricular Ejection Fraction (LVEF) less or equal 45% by means of echocardiography, radionuclide ventriculography or cardiac MRI and Sleep Disordered Breathing (SDB) (apnoea-hypopnoea-index (AHI > 15/h) with 50% central events and a central AHI ≥ 10/h, no change of medication and no hospitalization for more than 1 month before randomization and medical therapy according to the applicable guidelines (European Society of Cardiology (ESC) and American College of Cardiology/American Heart Association (ACC/AHA) respectively).

Primary Endpoints: Time to first event of:

  1. all cause mortality or unplanned hospitalisation/prolongation of hospitalisation for worsening heart failure
  2. cardiovascular mortality or unplanned hospitalisation/prolongation of hospitalisation for worsening heart failure.
  3. all cause mortality or all cause unplanned hospitalisation/prolongation of hospitalisation Heart transplantation, appropriate shock from implantable cardioverter-defibrillator (ICD), long term assist device (LTAD) insertion and survived resuscitation of sudden cardiac arrest are counted as cardiovascular death, survived resuscitation for other reasons is counted as all cause death.

The three combinations are not tested in parallel but in this hierarchical order.

Secondary Endpoints : Time until death, non cardiovascular death, cardiovascular death, hospitalization due to deterioration of heart failure or cardiovascular death, hospitalization for other reasons or death, hospitalization for cardiovascular cause or cardiovascular death, percent of follow-up (FU) days which patient survives and is not hospitalized for cardiovascular cause, percent of follow up days which patient survives and is not hospitalized for other reason, time to first adequate shock (in patients with ICD, evaluation of appropriateness will also be made by the ERC) or cardiovascular death, changes in NYHA class as compared to baseline, changes in difference in health costs between the two treatment groups, changes in QoL (Minnesota, Euroqol 5D (EQ5D)) as compared to baseline, changes in renal function (based on serum creatinine) as compared to baseline, changes in result of Six Minute Walking Test (6MWT) (50) as compared to baseline,changes of AHI and oxygen desaturation index compared to baseline, AHI below 10 per hour at twelve months and Oxygen desaturation index (ODI) below 5 per hour at twelve months, atrial fibrillation at follow-up visits.

Number and cost of hospitalizations (with tariff/diagnostic-related Group (DRG), diagnoses and procedures for calculating DRG or length of stay and level of care provided), cost of care (technology and service, nursing, physicians visit) related to ventilation, difference in utilities / QoL (Minnesota and EQ5D) compared to control arm, difference in cost of resources consumed, cost-efficacy, cost-utility. Secondary target parameters will be measured at the last follow up or at the last available observation within FU.

Scheduled follow up : Minimum follow up time will be 24 months, maximum about 70 months. There will be a final assessment for each patient at the end of the study.

Being tested
Europe: AutoSet CS (USA: VPAP Adapt SV)
Keywords
heart failure (HF), sleep disordered breathing (SDB), sleep apnea, left ventricular systolic dysfunction
Medical subject headings
Heart Failure, Sleep Apnea Syndromes, Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Europe: AutoSet CS (USA: VPAP Adapt SV)Device

    At least 3 hours average daily usage time

Study groups in NCT00733343
Study groupRoleWhat they receive
Treatment GroupActive comparatortreatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP (Variable Positive Airway Pressure) Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Receives: Device: Europe: AutoSet CS (USA: VPAP Adapt SV)
Control GroupNo interventionstandard medical therapy according to applicable guidelines (ESC, ACC/AHA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure

    Measured: time to first event, assessed for up to 70 weeks

  2. Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure

    Measured: time to first event, assessed for up to 70 weeks

  3. All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation

    Measured: time to first event, assessed for up to 70 weeks

Secondary outcomes (39)

  1. Death From Any Cause

    Measured: the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks

  2. Non-cardiovascular Death

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  3. Cardiovascular Death

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  4. Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  5. Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  6. Adequate Shock in Patients With ICD (Evaluation of Appropriateness Will Also be Made by the Endpoint Review Committee, ERC), Long-Term Atrial Defibrillator Insertion or Cardiovascular Death

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  7. First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  8. First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  9. Age Baseline

    Measured: 1 x at Baseline

  10. Body Weight Baseline

    Measured: 1 x at baseline

  11. Body Mass Index (BMI) Baseline

    Measured: 1 x baseline

  12. Left Ventricular Ejection Fraction at Baseline

    Measured: 1x at baseline

  13. Blood Pressure Systolic Baseline

    Measured: 1 x at baseline

  14. Blood Pressure Diastolic Baseline

    Measured: 1 x at baseline

  15. Hemoglobine Baseline

    Measured: 1 x at baseline

  16. Creatinine Baseline

    Measured: 1 x at baseline

  17. Glomerular Filtration Rate Baseline

    Measured: 1 x at baseline

  18. 6-Min Walk Distance

    Measured: 1 x at baseline

  19. Epworth Sleepiness Scale (ESS)

    Measure Description: ESS is a self-administered questionnaire. It contains 8 questions. Questions are rated on a 4-point Likert scale (0-3); 0= would never doze, 3=high Chance of dozing. Range of scores 0-24. Global score= sum of all item scores. Copyright (c)MW Johns

    Measured: 1 x at baseline

  20. Apnoea-Hypopnea-Index (AHI) at Baseline

    Measure Description: The AHI is an index to describe the severity of Sleep Apnea. Apnea is cessation of breathing during sleep. Hypopnea is diminished breathing during sleep. The number of Apneas and Hypopneas are added up and divided by hours of sleep (Apneas + Hypopneas per hour). An AHI ranging from 5-15 describes mild Sleep Apnea. AHI 15-30 describes moderate Sleep Apnea. AHI >30 describes severe Sleep Apnea.

    Measured: 1 x at baseline

  21. Central Apnoea Index/Total AHI

    Measure Description: Central apneas are partial or complete cessations of airflow caused by reduced or stopped neural Stimulation of the breathing muscles. For comparison: In obstructive apneas are caused by blocked airways that shut off the air although the breathing Stimulus is working.

    Measured: 1 x at baseline

  22. Central AHI/Total AHI at Baseline

    Measured: 1 x at baseline

  23. Oxygen Desaturation Index (ODI) at Baseline

    Number of oxygen desaturations per hour at baseline

    Measured: 1 x at baseline

  24. Oxygen Saturation Baseline

    Measured: 1 x at baseline

  25. Time With Oxygen Saturation Below 90%

    Measured: 1 x at baseline

  26. Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  27. Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  28. Changes in NYHA Classification as Compared to Baseline

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  29. Changes in QoL (Minnesota) as Compared to Baseline

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  30. Changes in Renal Function (Based on Serum Creatinine) as Compared to Baseline

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  31. Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  32. Changes of AHI and Oxygen Desaturation Index Compared to Baseline

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  33. AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  34. Atrial Fibrillation at Follow-up Visits

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  35. Number and Cost of Hospitalisations (With Tariff/DRG, Diagnoses and Procedures for Calculating DRG or Length of Stay and Level of Care Provided)

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  36. Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  37. Difference in Cost of Resources Consumed

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  38. Incremental Cost-efficacy Ratio

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

  39. Incremental Cost-utility Ratio

    Measured: the last follow up or at the last available observation within FU, assessed for up to 70 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00733343
Sponsor's protocol ID
01
Other IDs
ISRCTN19572887
Acronym
Serve-HF
Status last verified
Apr 2020
First submitted
14 Feb 2008
Last updated
12 May 2020
Data monitoring committee
Yes

Publications

  • Cowie MR, Wegscheider K, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Heart Failure. N Engl J Med. 2016 Feb 18;374(7):690-1. doi: 10.1056/NEJMc1515007. No abstract available.

    PubMed 26886528

  • Eulenburg C, Wegscheider K, Woehrle H, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Cowie MR. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modelling analysis. Lancet Respir Med. 2016 Nov;4(11):873-881. doi: 10.1016/S2213-2600(16)30244-2. Epub 2016 Aug 31.

    PubMed 27592224

  • Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Wegscheider K. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017 Aug 31;50(2):1601692. doi: 10.1183/13993003.01692-2016. Print 2017 Aug.

    PubMed 28860264

  • Tamisier R, Pepin JL, Woehrle H, Salvat M, Barone-Rochette G, Rocca C, Vettorazzi E, Teschler H, Cowie M, Levy P. Effect of adaptive servo-ventilation for central sleep apnoea in systolic heart failure on muscle sympathetic nerve activity: a SERVE-HF randomised ancillary study. Eur Respir J. 2023 Feb 9;61(2):2200384. doi: 10.1183/13993003.00384-2022. Print 2023 Feb.

    PubMed 36229051

  • Shafazand S, Badr MS. Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure. J Clin Sleep Med. 2016 Jan;12(1):147-50. doi: 10.5664/jcsm.5420. No abstract available.

    PubMed 26888594

  • Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.

    PubMed 26323938

Questions about this trial

What is this clinical trial studying?

A study testing Europe: AutoSet CS (USA: VPAP Adapt SV) in people with Heart Failure and Sleep Disordered Breathing, run by ResMed at 267 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 267 sites in Germany, France, Australia, Denmark, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time frame: time to first event, assessed for up to 70 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733343, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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