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

NCT ID: NCT00733343

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Heart Failure; Sleep Disordered Breathing

Study Design

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

Study Groups

Treatment Group

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)

Group Type: ACTIVE_COMPARATOR

Europe: AutoSet CS (USA: VPAP Adapt SV)

Intervention Type: DEVICE

At least 3 hours average daily usage time

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Europe: AutoSet CS (USA: VPAP Adapt SV)

At least 3 hours average daily usage time

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

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

Sponsors

CRI-The Clinical Research Institute GmbH

INDUSTRY

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Teschler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Essen

Martin Cowie, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Rivercity Private Hospital

Auchenflower, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St Vincents and Mercy Private Hospital

Melbourne, Victoria, Australia

Melbourne Sleep Disorders Centre

East Melbourne, Victoria 3002, Australia

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, Australia

St. Anne's University Hospital BRNO

Brno, , Czechia

Århus Universitets Hospital

Århus C, , Denmark

Århus Universitets Hospital Skejby

Århus N, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Dansk Center For Søvnmedicin

Glostrup Municipality, , Denmark

Glostrup Hospital

Glostrup Municipality, , Denmark

Helsinki University Hospital

Helsinki, , Finland

Unesta Research Centre

Tampere, , Finland

Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

Tampere, , Finland

Cardiologist Dr. Papola

Amnéville, , France

CHU Angers

Angers, , France

Centre Hospitalier d'Antibes Juan-les-Pins

Antibes, , France

Hopital Prive d'Antony

Antony, , France

CH Belfort

Belfort, , France

CH de Besancon

Besançon, , France

Centre Hospitalier de Béziers

Béziers, , France

Clinique du Tondu

Bordeaux, , France

Hôpital St. André

Bordeaux, , France

Praxis Cardiologique Dr. Puel

Bordeaux, , France

Praxis Cardiologique Dr. Wickers

Bordeaux, , France

CHU Bordeaux, Hopital Pellegrin

Bordeaux, , France

CHU de Caen

Caen, , France

Centre Hospitalier de Cannes

Cannes, , France

Hopital Henri Mondor

Créteil, , France

Hôpital Sud

Échirolles, , France

CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

Forbach, , France

CH de Forbach-Cardiology

Forbach, , France

Clinique Mutualiste des Eaux Claires

Grenoble, , France

CHU Grenoble, Hopital Michallon

Grenoble, , France

CH Haguenau

Haguenau, , France

Clinique de L'Union

L'Union, , France

CHU Lille- Hopital Cardiologique

Lille, , France

CHU Lille-Sleep medicine

Lille, , France

Polyclinique La Louviere

Lille, , France

Hospices Civils de Lyon, Hopital de la Croix-Rousse

Lyon, , France

CHR Metz, Hôpital de Bon-Secours

Metz, , France

CH Montbeliard

Montbéliard, , France

CHU de Montpellier

Montpellier, , France

CH Intercommunal André Grégoire

Montreuil, , France

CH de Mulhouse, Hopital Emile Muller

Mulhouse, , France

Clinique les Fleurs

Ollioules, , France

Hôpital Bichat

Paris, , France

CHU Tenon

Paris, , France

CHU de Bordeaux, Hopital Haut Leveque

Pessac, , France

CHU de Poitiers

Poitiers, , France

Cabinet de cardiologie

Pont-à-Mousson, , France

CH Rene Dubos

Pontoise, , France

Polyclinique Saint-Laurent

Rennes, , France

CHU de Rouen, Hopital de Bois Guillaume

Rouen, , France

CH Lemire - St Avold

Saint-Avold, , France

CH de St Dié des Vosges

Saint-Dié, , France

CHU de Saint-Etienne, Hopital Nord

Saint-Etienne, , France

Clinique des Trois Frontières

Saint-Louis, , France

CHU Toulouse, Hopital de Rangueil

Toulouse, , France

CHU Toulouse, Hopital Larrey

Toulouse, , France

CH Trouville

Trouville, , France

CHU de Nancy, Hopital Brabois

Vandœuvre-lès-Nancy, , France

Ch St. Nicolas

Verdun, , France

Cardiopraxis Ingelheim

Ingelheim, Rhineland-Palatinate, Germany

Praxis Dr. Frieske

Aachen, , Germany

Universitätsklinikum Aachen

Aachen, , Germany

DRK Krankenhaus

Alzey, , Germany

Gemeinschaftspraxis Weiß / Dr. Heesing

Arnsberg, , Germany

Zentralklinikum Bad Berka

Bad Berka, , Germany

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Klinik Lazariterhof

Bad Krozingen, , Germany

Schlaflabor Breisgau

Bad Krozingen, , Germany

Praxis Dr. Bauer

Bad Mergentheim, , Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Oberlausitz-Kliniken gGmbH

Bautzen, , Germany

Kardiologie Brühl

Bergheim, , Germany

Kardiopraxis Rheinberg

Bergisch Gladbach, , Germany

Charité Campus Mitte - Kardiologie

Berlin, , Germany

Charité Campus Mitte CCM- Schlafmedizinisches Zentrum

Berlin, , Germany

POLIKUM Friedenau

Berlin, , Germany

Gemeinschaftspraxis Groß-Ziethener Chaussee

Berlin, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Evangelische Lungenfachklinik Buch

Berlin, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Charité Campus Virchow Klinikum

Berlin, , Germany

Praxis Westend

Berlin, , Germany

Herzzentrum Brandenburg

Bernau, , Germany

Praxis für Lunge, Herz und Schlaf

Bielefeld, , Germany

Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

Bochum, , Germany

Universitätsklinikum Bergmannsheil

Bochum, , Germany

Augusta Krankenanstalten Bochum

Bochum, , Germany

St.-Josephs-Hospital

Bochum, , Germany

Kardiologie Kemnade

Bochum, , Germany

Kardiologische Praxis Dr. Staubach

Bochum, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Kardiologische Praxis Marschner

Bonn, , Germany

Helios Klinikum Borna

Borna, , Germany

Gemeinschaftspraxis Kardiologie

Bottrop, , Germany

Klinikum Bremen Ost

Bremen, , Germany

Kardiologie Brühl

Brühl, , Germany

Mediclin Rehazentrum Spreewald

Burg, , Germany

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, , Germany

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, , Germany

MVZ am Küchwald

Chemnitz, , Germany

Klinikum Coburg GmbH

Coburg, , Germany

St.-Vinzenz Hospital

Cologne, , Germany

Kardiologische Praxis Dr. Fritsch

Cologne, , Germany

Malteser Krankenhaus St.Hildegardis

Cologne, , Germany

Prof. Franzen Institut

Cologne, , Germany

Praxis Dr. Anselm Bäumer

Cologne, , Germany

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, , Germany

Fachkrankenhaus Coswig

Coswig, , Germany

Carl-Thiem-Klinikum gGmbH

Cottbus, , Germany

Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

Cottbus, , Germany

MECS Cottbus GmbH

Cottbus, , Germany

Praxis Dr. Hecker

Dortmund, , Germany

Kardiologische Praxis Dr. Golling

Dortmund, , Germany

Clinical Trial Site Services

Dortmund, , Germany

Kardiologische Praxis Dr. Wetzel

Dortmund, , Germany

Kardiologische Praxis Dr. Lodde

Dortmund, , Germany

Kardiologische Praxis Dr. Dröse

Dortmund, , Germany

Facharztzentrum Dresden-Neustadt GbR

Dresden, , Germany

Gemeinschaftspraxis Dres. Schmidt/Gronke

Dresden, , Germany

Praxis Dr. Hohensee

Dresden, , Germany

Herzzentrum Universität Dresden

Dresden, , Germany

goMedus Gesundheitszentrum

Düsseldorf, , Germany

Kardiologische Praxis Dr. Horowitz

Düsseldorf, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Kardiologische Praxis Dr. Raff

Düsseldorf, , Germany

Florence-Nightingale Krankenhaus

Düsseldorf, , Germany

Kardiologie Oberkassel

Düsseldorf, , Germany

Gemeinschaftspraxis PD. Dr. Lankisch

Düsseldorf, , Germany

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

Emmendingen, , Germany

Helios Klinikum Erfurt-Kardiologie

Erfurt, , Germany

Helios Klinikum Erfurt-Schlafmedizin

Erfurt, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Westdeutsches Herzzentrum, Universitätsklinikum Essen

Essen, , Germany

Kardiologische Praxis Dr. Cord Müller

Essen, , Germany

Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

Essen, , Germany

Kardiologische Praxis Prof. Winter

Essen, , Germany

Kardiologie Praxis Dr. Bonnekamp

Essen, , Germany

Praxis Dr. Tekiyeh

Essen, , Germany

Elisabeth-Krankenhaus Essen

Essen, , Germany

Ruhrlandklinik Essen

Essen, , Germany

Praxis Dr. Rau

Essen, , Germany

Kath. Kliniken Essen / Philippusstift

Essen, , Germany

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, , Germany

Kardiologische Praxis Dr. Kruse

Forst, , Germany

CardioVasculäres Centrum Frankfurt

Frankfurt, , Germany

Praxis Dr. Diedrichs

Frechen, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Gemeinschaftspraxis Dres. Böhmeke/Schmidt

Gladbeck, , Germany

Kardiologische Praxis Dr. Hug

Günzburg, , Germany

Kardiologische Praxis Gütersloh

Gütersloh, , Germany

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, , Germany

Kardiologische Praxis Dr. Arens

Hagen, , Germany

Gemeinschaftspraxis Dres. Subin/Lutter

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Internistenpraxis Alstertal Hamburg

Hamburg, , Germany

Kardiologische Praxis Dr. Cierpka

Hanover, , Germany

Praxis Dr. Hötte

Hanover, , Germany

Siloah Krankenhaus

Hanover, , Germany

Kardiologische Praxis Dr. Hartung

Hanover, , Germany

MH Hannover

Hanover, , Germany

Klinikum Hannover Oststadt-Heidehaus

Hanover, , Germany

Praxis Dr. Durak

Heidelberg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, , Germany

Lungenklinik Hemer

Hemer, , Germany

Kardiologische Praxis 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

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, , Germany

Ambulantes Herzzentrum Kassel

Kassel, , Germany

Kardiologische Praxis Dr. Siegfried Frickel

Kempen, , Germany

Klinikum Dahme-Spreewald GmbH

Königs Wusterhausen, , Germany

Praxis Dr. Krater

Krefeld, , Germany

Helios Klinikum Krefeld

Krefeld, , Germany

Universitätsklinikum Leipzig-Herzzentrum

Leipzig, , Germany

Helios Krankenhaus Leisnig

Leisnig, , Germany

Gemeinschaftspraxis Dr. Hilgedieck/Sava

Lengerich, , Germany

Kardiologische Praxis Dr. Faber

Lindlar, , Germany

Ärztezentrum Holthausen-Biene

Lingen, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

Lübeck, , Germany

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Cardiopraxis Ingelheim

Mainz, , Germany

Universitätsklinikum Mannheim-Schlafmedizin

Mannheim, , Germany

Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

Mannheim, , Germany

Gemeinschaftspraxis für Herz & Gefäße

Mannheim, , Germany

Universitätsklinik Mannheim-Kardiologie

Mannheim, , Germany

Gemeinschaftspraxis Dres. Brandt / Jakobs

Mannheim, , Germany

Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

Marburg, , Germany

Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

Marburg, , Germany

Praxis Dr. Schnabel

Meissen, , Germany

Gemeinschaftspraxis Dr. Jocham

Memmingen, , Germany

Praxis Für Kardiologie Dr. med. Menz

Menden, , Germany

Krankenhaus Bethanien

Moers, , Germany

Kardiologische Praxis Dr. Schön

Mühldorf, , Germany

Evangelisches Krankenhaus Mülheim

Mülheim, , Germany

Kardiologie am Rotkreuzplatz

München, , Germany

Lungenärzte am Rotkreuzplatz

München, , Germany

Gemeinschaftspraxis Dres. Wauer / Windstetter

München, , Germany

Kardiologische Praxis Dr. Herholz

München, , Germany

Klinik Augustinum München

München, , Germany

Praxis Dres. Böhme/Linke

München, , Germany

Kardiologische Praxis Dr. Muradi

Münster, , Germany

Universitätsklinikum Münster

Münster, , Germany

Praxis für Kardiologie Dr. med. Hewing

Münster, , Germany

Lukaskrankenhaus GmbH

Neuss, , Germany

Kardiologische Praxis Nienburg

Nienburg, , Germany

Klinikum Nürnberg Nord

Nuremberg, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Kardiologische Praxis Dr. Gumbrecht

Ochtrup, , Germany

Kardiologische Praxis Dr. Wiethölter

Radebeul, , Germany

Praxis für Kardiologie Ratingen

Ratingen, , Germany

Praxis Dr. Fröhlich

Ratingen, , Germany

DRK Krankenhaus Mölln-Ratzeburg

Ratzeburg, , Germany

Ambulantes Cardiovaskuläres Centrum

Ravensburg, , Germany

Gemeinschaftspraxis Dr. Weber/Dr. Feja

Recklinghausen, , Germany

Knappschafts-Krankenhaus Recklinghausen

Recklinghausen, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Krankenhaus Reinbek St. Adolf-Stift

Reinbek, , Germany

Praxis Dr. Hein

Reinbek, , Germany

Praxis Dr. Nebel

Rheine, , Germany

Praxis Dr. Kestermann

Rheine, , Germany

Praxis Dr. Ebeling

Schönefeld, , Germany

Kardiologische Praxis Dr. Heinze

Schwerte, , Germany

Praxisgemeinschaft Cardio-Soest

Soest, , Germany

Facharztzentrum Sonneberg

Sonneberg, , Germany

Kreiskrankenhaus Stollberg GmbH

Stollberg, , Germany

Klinikum Uelzen GmbH

Uelzen, , Germany

Herzklinik Ulm Dr. Haerer und Partner

Ulm, , Germany

Zentrum für Innere Medizin Uni Ulm

Ulm, , Germany

Katharinen Hospital Unna

Unna, , Germany

Kardiologische Praxis Dr. Burkhard-Meier

Viersen, , Germany

Praxis Dr. Gerritsen

Waldkraiburg, , Germany

Fachkliniken Wangen

Wangen, , Germany

Stiftungsklinik Weißenhorn

Weißenhorn, , Germany

Kardiologische Praxis Dr. Vrettos

Witten, , Germany

Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

Worms, , Germany

Missionsärztliche Klinik Würzburg

Würzburg, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Evangel. Khs Zweibrücken

Zweibrücken, , Germany

University Medical Center Groningen

Groningen, , Netherlands

Ullevål University Hospital

Oslo, , Norway

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Stavanger AS

Stavanger, , Norway

Sahlgrenska University Hospital / Östra

Gothenburg, , Sweden

Sahlgrenska University Hospital / Östra

Gothenburg, , Sweden

Specialistläkarmottagning Residenset AB

Jönköping, , Sweden

Skaraborgs Hospital

Lidköping, , Sweden

Linköping University Hospital

Linköping, , Sweden

Cardiocentro Ticino

Lugano, , Switzerland

Ospedale Regionale di Lugano

Lugano, , Switzerland

Castle Hill Hospital

Cottingham, East Yorkshire, United Kingdom

Chesterfield Royal Hospital

Chesterfield, , United Kingdom

Brompton Hospital

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Musgrove Park Hospital

Taunton, , United Kingdom

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, , United Kingdom

Countries

Australia; Czechia; Denmark; Finland; France; Germany; Netherlands; Norway; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: RESULT

PMID: 26886528 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27592224 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28860264 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36229051 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26888594 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26323938 (View on PubMed)

Other Identifiers

ISRCTN19572887

Identifier Type: OTHER

Identifier Source: secondary_id

01

Identifier Type: -

Identifier Source: org_study_id