NCT00733343

Brief 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 (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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,325

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable heart-failure

Geographic Reach
11 countries

267 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

April 1, 2020

Enrollment Period

7.2 years

First QC Date

February 14, 2008

Results QC Date

April 28, 2017

Last Update Submit

April 29, 2020

Conditions

Keywords

heart failure (HF)sleep disordered breathing (SDB)sleep apnealeft ventricular systolic dysfunction

Outcome Measures

Primary Outcomes (3)

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

    time to first event, assessed for up to 70 weeks

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

    time to first event, assessed for up to 70 weeks

  • All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation

    time to first event, assessed for up to 70 weeks

Secondary Outcomes (39)

  • Death From Any Cause

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

  • Non-cardiovascular Death

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

  • Cardiovascular Death

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

  • Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure

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

  • Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death

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

  • +34 more secondary outcomes

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP (Variable Positive Airway Pressure) Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

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

Control Group

NO INTERVENTION

standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

Interventions

At least 3 hours average daily usage time

Treatment Group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (267)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Rivercity Private Hospital

Auchenflower, Queensland, 4066, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

St Vincents and Mercy Private Hospital

Melbourne, Victoria, 3065, Australia

Location

Melbourne Sleep Disorders Centre

East Melbourne, Victoria 3002, 3002, Australia

Location

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, 6009, Australia

Location

St. Anne's University Hospital BRNO

Brno, 65691, Czechia

Location

Århus Universitets Hospital

Århus C, 8000, Denmark

Location

Århus Universitets Hospital Skejby

Århus N, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Dansk Center For Søvnmedicin

Glostrup Municipality, 2600, Denmark

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Helsinki University Hospital

Helsinki, 00290, Finland

Location

Unesta Research Centre

Tampere, 33520, Finland

Location

Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

Tampere, 33521, Finland

Location

Cardiologist Dr. Papola

Amnéville, 57360, France

Location

CHU Angers

Angers, 49933, France

Location

Centre Hospitalier d'Antibes Juan-les-Pins

Antibes, 06606, France

Location

Hopital Prive d'Antony

Antony, 92166, France

Location

CH Belfort

Belfort, 90000, France

Location

CH de Besancon

Besançon, 25000, France

Location

Centre Hospitalier de Béziers

Béziers, 34525, France

Location

Clinique du Tondu

Bordeaux, 33000, France

Location

Hôpital St. André

Bordeaux, 33000, France

Location

Praxis Cardiologique Dr. Puel

Bordeaux, 33000, France

Location

Praxis Cardiologique Dr. Wickers

Bordeaux, 33000, France

Location

CHU Bordeaux, Hopital Pellegrin

Bordeaux, 33076, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Hospitalier de Cannes

Cannes, 06401, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Hôpital Sud

Échirolles, 38434, France

Location

CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

Forbach, 57604, France

Location

CH de Forbach-Cardiology

Forbach, 57604, France

Location

Clinique Mutualiste des Eaux Claires

Grenoble, 38000, France

Location

CHU Grenoble, Hopital Michallon

Grenoble, 38043, France

Location

CH Haguenau

Haguenau, 67504, France

Location

Clinique de L'Union

L'Union, 31240, France

Location

CHU Lille- Hopital Cardiologique

Lille, 59037, France

Location

CHU Lille-Sleep medicine

Lille, 59037, France

Location

Polyclinique La Louviere

Lille, 59042, France

Location

Hospices Civils de Lyon, Hopital de la Croix-Rousse

Lyon, 69317, France

Location

CHR Metz, Hôpital de Bon-Secours

Metz, 57000, France

Location

CH Montbeliard

Montbéliard, 25209, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CH Intercommunal André Grégoire

Montreuil, 93105, France

Location

CH de Mulhouse, Hopital Emile Muller

Mulhouse, 68070, France

Location

Clinique les Fleurs

Ollioules, 83190, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CHU Tenon

Paris, 75790, France

Location

CHU de Bordeaux, Hopital Haut Leveque

Pessac, 33600, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Cabinet de cardiologie

Pont-à-Mousson, 54700, France

Location

CH Rene Dubos

Pontoise, 95303, France

Location

Polyclinique Saint-Laurent

Rennes, 35706, France

Location

CHU de Rouen, Hopital de Bois Guillaume

Rouen, 76031, France

Location

CH Lemire - St Avold

Saint-Avold, BP 30011, France

Location

CH de St Dié des Vosges

Saint-Dié, 88187, France

Location

CHU de Saint-Etienne, Hopital Nord

Saint-Etienne, 42055, France

Location

Clinique des Trois Frontières

Saint-Louis, 68300, France

Location

CHU Toulouse, Hopital de Rangueil

Toulouse, 31059, France

Location

CHU Toulouse, Hopital Larrey

Toulouse, 31059, France

Location

CH Trouville

Trouville, 14360, France

Location

CHU de Nancy, Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Ch St. Nicolas

Verdun, 55100, France

Location

Cardiopraxis Ingelheim

Ingelheim, Rhineland-Palatinate, 55218, Germany

Location

Praxis Dr. Frieske

Aachen, 52062, Germany

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

DRK Krankenhaus

Alzey, 55232, Germany

Location

Gemeinschaftspraxis Weiß / Dr. Heesing

Arnsberg, 59821, Germany

Location

Zentralklinikum Bad Berka

Bad Berka, 99437, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Klinik Lazariterhof

Bad Krozingen, 79189, Germany

Location

Schlaflabor Breisgau

Bad Krozingen, 79189, Germany

Location

Praxis Dr. Bauer

Bad Mergentheim, 97980, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Oberlausitz-Kliniken gGmbH

Bautzen, 02625, Germany

Location

Kardiologie Brühl

Bergheim, 50126, Germany

Location

Kardiopraxis Rheinberg

Bergisch Gladbach, 51465, Germany

Location

Charité Campus Mitte - Kardiologie

Berlin, 10117, Germany

Location

Charité Campus Mitte CCM- Schlafmedizinisches Zentrum

Berlin, 10117, Germany

Location

POLIKUM Friedenau

Berlin, 12157, Germany

Location

Gemeinschaftspraxis Groß-Ziethener Chaussee

Berlin, 12355, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Evangelische Lungenfachklinik Buch

Berlin, 13125, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

Location

Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Praxis Westend

Berlin, 14050, Germany

Location

Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Praxis für Lunge, Herz und Schlaf

Bielefeld, 33617, Germany

Location

Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

Bochum, 44787, Germany

Location

Universitätsklinikum Bergmannsheil

Bochum, 44789, Germany

Location

Augusta Krankenanstalten Bochum

Bochum, 44791, Germany

Location

St.-Josephs-Hospital

Bochum, 44791, Germany

Location

Kardiologie Kemnade

Bochum, 44797, Germany

Location

Kardiologische Praxis Dr. Staubach

Bochum, 44866, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Kardiologische Praxis Marschner

Bonn, 53225, Germany

Location

Helios Klinikum Borna

Borna, 04552, Germany

Location

Gemeinschaftspraxis Kardiologie

Bottrop, 46236, Germany

Location

Klinikum Bremen Ost

Bremen, 28325, Germany

Location

Kardiologie Brühl

Brühl, 50321, Germany

Location

Mediclin Rehazentrum Spreewald

Burg, 03096, Germany

Location

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, 44575, Germany

Location

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, 44577, Germany

Location

MVZ am Küchwald

Chemnitz, 09113, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

St.-Vinzenz Hospital

Cologne, 50733, Germany

Location

Kardiologische Praxis Dr. Fritsch

Cologne, 50737, Germany

Location

Malteser Krankenhaus St.Hildegardis

Cologne, 50931, Germany

Location

Prof. Franzen Institut

Cologne, 50937, Germany

Location

Praxis Dr. Anselm Bäumer

Cologne, 51065, Germany

Location

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, 51105, Germany

Location

Fachkrankenhaus Coswig

Coswig, 01640, Germany

Location

Carl-Thiem-Klinikum gGmbH

Cottbus, 03042, Germany

Location

Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

Cottbus, 03050, Germany

Location

MECS Cottbus GmbH

Cottbus, 03050, Germany

Location

Praxis Dr. Hecker

Dortmund, 44135, Germany

Location

Kardiologische Praxis Dr. Golling

Dortmund, 44137, Germany

Location

Clinical Trial Site Services

Dortmund, 44141, Germany

Location

Kardiologische Praxis Dr. Wetzel

Dortmund, 44141, Germany

Location

Kardiologische Praxis Dr. Lodde

Dortmund, 44147, Germany

Location

Kardiologische Praxis Dr. Dröse

Dortmund, 44263, Germany

Location

Facharztzentrum Dresden-Neustadt GbR

Dresden, 01099, Germany

Location

Gemeinschaftspraxis Dres. Schmidt/Gronke

Dresden, 01219, Germany

Location

Praxis Dr. Hohensee

Dresden, 01277, Germany

Location

Herzzentrum Universität Dresden

Dresden, 01307, Germany

Location

goMedus Gesundheitszentrum

Düsseldorf, 40212, Germany

Location

Kardiologische Praxis Dr. Horowitz

Düsseldorf, 40215, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Kardiologische Praxis Dr. Raff

Düsseldorf, 40237, Germany

Location

Florence-Nightingale Krankenhaus

Düsseldorf, 40489, Germany

Location

Kardiologie Oberkassel

Düsseldorf, 40545, Germany

Location

Gemeinschaftspraxis PD. Dr. Lankisch

Düsseldorf, 40597, Germany

Location

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

Emmendingen, 79312, Germany

Location

Helios Klinikum Erfurt-Kardiologie

Erfurt, 99089, Germany

Location

Helios Klinikum Erfurt-Schlafmedizin

Erfurt, 99089, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Westdeutsches Herzzentrum, Universitätsklinikum Essen

Essen, 45122, Germany

Location

Kardiologische Praxis Dr. Cord Müller

Essen, 45131, Germany

Location

Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

Essen, 45131, Germany

Location

Kardiologische Praxis Prof. Winter

Essen, 45134, Germany

Location

Kardiologie Praxis Dr. Bonnekamp

Essen, 45136, Germany

Location

Praxis Dr. Tekiyeh

Essen, 45136, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, 45138, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Praxis Dr. Rau

Essen, 45276, Germany

Location

Kath. Kliniken Essen / Philippusstift

Essen, 45359, Germany

Location

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, 55237, Germany

Location

Kardiologische Praxis Dr. Kruse

Forst, 03149, Germany

Location

CardioVasculäres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Praxis Dr. Diedrichs

Frechen, 50226, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Gemeinschaftspraxis Dres. Böhmeke/Schmidt

Gladbeck, 45964, Germany

Location

Kardiologische Praxis Dr. Hug

Günzburg, 89312, Germany

Location

Kardiologische Praxis Gütersloh

Gütersloh, 33334, Germany

Location

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, 58095, Germany

Location

Kardiologische Praxis Dr. Arens

Hagen, 58095, Germany

Location

Gemeinschaftspraxis Dres. Subin/Lutter

Hamburg, 20095, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

Location

Internistenpraxis Alstertal Hamburg

Hamburg, 22399, Germany

Location

Kardiologische Praxis Dr. Cierpka

Hanover, 30159, Germany

Location

Praxis Dr. Hötte

Hanover, 30449, Germany

Location

Siloah Krankenhaus

Hanover, 30449, Germany

Location

Kardiologische Praxis Dr. Hartung

Hanover, 30559, Germany

Location

MH Hannover

Hanover, 30625, Germany

Location

Klinikum Hannover Oststadt-Heidehaus

Hanover, 30659, Germany

Location

Praxis Dr. Durak

Heidelberg, 69115, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Kardiologische Praxis Dr. Furche

Herne, 44623, Germany

Location

Gemeinschaftspraxis Dr. Bruch

Herne, 44629, Germany

Location

Kardiologische Praxis Dr. Schlichting

Herne, 44649, Germany

Location

Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

Herne, 44651, Germany

Location

St. Elisabeth-Hospital Herten gGmbH

Herten, 45699, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, 97753, Germany

Location

Ambulantes Herzzentrum Kassel

Kassel, 34121, Germany

Location

Kardiologische Praxis Dr. Siegfried Frickel

Kempen, 47906, Germany

Location

Klinikum Dahme-Spreewald GmbH

Königs Wusterhausen, 15711, Germany

Location

Praxis Dr. Krater

Krefeld, 47799, Germany

Location

Helios Klinikum Krefeld

Krefeld, 47805, Germany

Location

Universitätsklinikum Leipzig-Herzzentrum

Leipzig, 04289, Germany

Location

Helios Krankenhaus Leisnig

Leisnig, 04703, Germany

Location

Gemeinschaftspraxis Dr. Hilgedieck/Sava

Lengerich, 49525, Germany

Location

Kardiologische Praxis Dr. Faber

Lindlar, 51784, Germany

Location

Ärztezentrum Holthausen-Biene

Lingen, 49808, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, 23538, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

Lübeck, 23538, Germany

Location

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

Location

Cardiopraxis Ingelheim

Mainz, 55116, Germany

Location

Universitätsklinikum Mannheim-Schlafmedizin

Mannheim, 68135, Germany

Location

Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

Mannheim, 68161, Germany

Location

Gemeinschaftspraxis für Herz & Gefäße

Mannheim, 68161, Germany

Location

Universitätsklinik Mannheim-Kardiologie

Mannheim, 68167, Germany

Location

Gemeinschaftspraxis Dres. Brandt / Jakobs

Mannheim, 68305, Germany

Location

Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

Marburg, 35033, Germany

Location

Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

Marburg, 35043, Germany

Location

Praxis Dr. Schnabel

Meissen, 01662, Germany

Location

Gemeinschaftspraxis Dr. Jocham

Memmingen, 87700, Germany

Location

Praxis Für Kardiologie Dr. med. Menz

Menden, 58706, Germany

Location

Krankenhaus Bethanien

Moers, 47441, Germany

Location

Kardiologische Praxis Dr. Schön

Mühldorf, 84453, Germany

Location

Evangelisches Krankenhaus Mülheim

Mülheim, 45468, Germany

Location

Kardiologie am Rotkreuzplatz

München, 80634, Germany

Location

Lungenärzte am Rotkreuzplatz

München, 80634, Germany

Location

Gemeinschaftspraxis Dres. Wauer / Windstetter

München, 80799, Germany

Location

Kardiologische Praxis Dr. Herholz

München, 80809, Germany

Location

Klinik Augustinum München

München, 81375, Germany

Location

Praxis Dres. Böhme/Linke

München, 81667, Germany

Location

Kardiologische Praxis Dr. Muradi

Münster, 29633, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Praxis für Kardiologie Dr. med. Hewing

Münster, 48151, Germany

Location

Lukaskrankenhaus GmbH

Neuss, 41464, Germany

Location

Kardiologische Praxis Nienburg

Nienburg, 31582, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Kardiologische Praxis Dr. Gumbrecht

Ochtrup, 48607, Germany

Location

Kardiologische Praxis Dr. Wiethölter

Radebeul, 01445, Germany

Location

Praxis für Kardiologie Ratingen

Ratingen, 40878, Germany

Location

Praxis Dr. Fröhlich

Ratingen, 40885, Germany

Location

DRK Krankenhaus Mölln-Ratzeburg

Ratzeburg, 23909, Germany

Location

Ambulantes Cardiovaskuläres Centrum

Ravensburg, 88212, Germany

Location

Gemeinschaftspraxis Dr. Weber/Dr. Feja

Recklinghausen, 45657, Germany

Location

Knappschafts-Krankenhaus Recklinghausen

Recklinghausen, 45657, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Krankenhaus Reinbek St. Adolf-Stift

Reinbek, 21465, Germany

Location

Praxis Dr. Hein

Reinbek, 21465, Germany

Location

Praxis Dr. Nebel

Rheine, 48429, Germany

Location

Praxis Dr. Kestermann

Rheine, 48431, Germany

Location

Praxis Dr. Ebeling

Schönefeld, 12529, Germany

Location

Kardiologische Praxis Dr. Heinze

Schwerte, 58239, Germany

Location

Praxisgemeinschaft Cardio-Soest

Soest, 59494, Germany

Location

Facharztzentrum Sonneberg

Sonneberg, 96515, Germany

Location

Kreiskrankenhaus Stollberg GmbH

Stollberg, 09366, Germany

Location

Klinikum Uelzen GmbH

Uelzen, 29525, Germany

Location

Herzklinik Ulm Dr. Haerer und Partner

Ulm, 89077, Germany

Location

Zentrum für Innere Medizin Uni Ulm

Ulm, 89081, Germany

Location

Katharinen Hospital Unna

Unna, 59423, Germany

Location

Kardiologische Praxis Dr. Burkhard-Meier

Viersen, 41747, Germany

Location

Praxis Dr. Gerritsen

Waldkraiburg, 84478, Germany

Location

Fachkliniken Wangen

Wangen, 88239, Germany

Location

Stiftungsklinik Weißenhorn

Weißenhorn, 89264, Germany

Location

Kardiologische Praxis Dr. Vrettos

Witten, 58452, Germany

Location

Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

Worms, 67547, Germany

Location

Missionsärztliche Klinik Würzburg

Würzburg, 97074, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Evangel. Khs Zweibrücken

Zweibrücken, 66482, Germany

Location

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Ullevål University Hospital

Oslo, 0407, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Stavanger AS

Stavanger, 4011, Norway

Location

Sahlgrenska University Hospital / Östra

Gothenburg, 41345, Sweden

Location

Sahlgrenska University Hospital / Östra

Gothenburg, U/6 85, Sweden

Location

Specialistläkarmottagning Residenset AB

Jönköping, 55316, Sweden

Location

Skaraborgs Hospital

Lidköping, 53185, Sweden

Location

Linköping University Hospital

Linköping, 58185, Sweden

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Castle Hill Hospital

Cottingham, East Yorkshire, HU165JQ, United Kingdom

Location

Chesterfield Royal Hospital

Chesterfield, Calow S44 5DX, United Kingdom

Location

Brompton Hospital

London, SW36NP, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart FailureSleep Apnea SyndromesVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVentricular Dysfunction

Results Point of Contact

Title
Martin R. Cowie, MD
Organization
Department of Cardiology, Imperial College London, Dovehouse St., London SW3 6LY, United Kingdom

Study Officials

  • Helmut Teschler, Prof.

    Universitätsklinikum Essen

    PRINCIPAL INVESTIGATOR
  • Martin Cowie, Prof.

    National Heart and Lung Institute (NHLI) Brompton Hospital, London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

August 13, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

May 12, 2020

Results First Posted

May 12, 2020

Record last verified: 2020-04

Locations