Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure (Serve-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Clinical Research Institute GmbH
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00733343
First received: February 14, 2008
Last updated: September 18, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Sleep Disordered Breathing
Device: Europe: AutoSet CS 2 (USA: VPAP Adapt SV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • 1) all cause mortality or unplanned hospitalization for worsening heart failure [ Time Frame: time to first event ] [ Designated as safety issue: No ]
  • 2) cardiovascular mortality or unplanned hospitalization for worsening heart failure [ Time Frame: time to first event ] [ Designated as safety issue: No ]
  • 3) all cause mortality or all cause hospitalization [ Time Frame: time to first event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time until death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time until non-cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time until cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time until unplanned hospitalization due to worsening of heart failure or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time until unplanned hospitalization for other reasons or death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time until unplanned hospitalization for cardiovascular cause or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Time to first adequate shock in patients with ICD (evaluation of appropriateness will also be made by the ERC) or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Percent of follow up days which patient survives and is not hospitalized for cardiovascular cause [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Percent of follow up days which patient survives and is not hospitalized for other reasons [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Changes in NYHA classification as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Difference in health costs between the two treatment groups [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Changes in QoL (Minnesota) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Changes in renal function (based on serum creatinine) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Changes in Six Minute Walking Distance (6MWD) (50) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
  • Number and cost of hospitalisations (with tariff/DRG, diagnoses and procedures for calculating DRG or length of stay and level of care provided) [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Cost of care (technology and service, nursing, physicians visit) related to ventilation [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Difference in utilities / QoL (Minnesota and EQ5D) compared to control arm [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Difference in cost of resources consumed [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Cost-efficacy [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Cost-utility [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • AHI and oxygen desaturation index [ Time Frame: Compared to baseline ] [ Designated as safety issue: No ]
    Changes of AHI and oxygen desaturation index compared to baseline

  • Changes in AHI and ODI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AHI below 10 per hour at twelve months and ODI below 5 per hour at twelve months

  • Atrial Fibrillation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Atrial fibrillation at follow-up visits


Estimated Enrollment: 1313
Study Start Date: February 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group
treatment with Adaptive Servoventilation + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Device: Europe: AutoSet CS 2 (USA: VPAP Adapt SV)
At least 3 hours average daily usage time
No Intervention: Control Group
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 inhibitors/ ARB 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/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 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-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733343

  Hide Study Locations
Locations
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne Sleep Disorders Centre
East Melbourne, Victoria, Australia, 3002
St Vincents and Mercy Private Hospital
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Hollywood Private Hospital (CVS)
Nedlands, Western Australia, Australia, 6009
Czech Republic
St. Anne's University Hospital BRNO
Brno, Czech Republic, 65691
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Rigshospitalet
Copenhagen, Denmark, 2100
Dansk Center For Søvnmedicin
Glostrup, Denmark, 2600
Glostrup Hospital
Glostrup, Denmark, 2600
Århus Universitets Hospital
Århus C, Denmark, 8000
Århus Universitets Hospital Skejby
Århus N, Denmark, 8200
Finland
Helsinki University Hospital
Helsinki, Finland, 00290
Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
Tampere, Finland, 33521
Unesta Research Centre
Tampere, Finland, 33520
France
Cardiologist Dr. Papola
Amneville, France, 57360
CHU Angers
Angers, France, 49933
Centre Hospitalier d'Antibes Juan-les-Pins
Antibes, France, 06606
Hopital Prive d'Antony
Antony, France, 92166
CH Belfort
Belfort, France, 90000
CH de Besancon
Besancon, France, 25000
Centre Hospitalier de Béziers
Beziers, France, 34525
Praxis Cardiologique Dr. Wickers
Bordeaux, France, 33000
Praxis Cardiologique Dr. Puel
Bordeaux, France, 33000
Clinique du Tondu
Bordeaux, France, 33000
Hôpital St. André
Bordeaux, France, 33000
CHU Bordeaux, Hopital Pellegrin
Bordeaux, France, 33076
CHU de Caen
Caen Cedex, France, 14033
Centre Hospitalier de Cannes
Cannes, France, 06401
Hopital Henri Mondor
Creteil, France, 94010
Hôpital Sud
Echirolles, France, 38434
CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology
Forbach, France, 57604
CH de Forbach-Cardiology
Forbach, France, 57604
CHU Grenoble, Hopital Michallon
Grenoble, France, 38043
Clinique Mutualiste des Eaux Claires
Grenoble, France, 38000
CH Haguenau
Haguenau, France, 67504
Clinique de L'Union
L'Union, France, 31240
Polyclinique La Louviere
Lille, France, 59042
CHU Lille- Hopital Cardiologique
Lille, France, 59037
CHU Lille-Sleep medicine
Lille, France, 59037
Hospices Civils de Lyon, Hopital de la Croix-Rousse
Lyon, France, 69317
CHR Metz, Hôpital de Bon-Secours
Metz, France, 57000
CH Montbeliard
Montbeliard, France, 25209
CHU de Montpellier
Montpellier, France, 34295
CH Intercommunal André Grégoire
Montreuil, France, 93105
CH de Mulhouse, Hopital Emile Muller
Mulhouse, France, 68070
Clinique les Fleurs
Ollioules, France, 83190
Hôpital Bichat
Paris, France, 75018
CHU Tenon
Paris, France, 75790
CHU de Bordeaux, Hopital Haut Leveque
Pessac, France, 33600
CHU de Poitiers
Poitiers, France, 86000
Cabinet de cardiologie
Pont-à-mousson, France, 54700
CH Rene Dubos
Pontoise, France, 95303
Polyclinique Saint-Laurent
Rennes, France, 35706
CHU de Rouen, Hopital de Bois Guillaume
Rouen, France, 76031
CH Lemire - St Avold
Saint Avold, France, BP 30011
Clinique des Trois Frontières
Saint Louis, France, 68300
CHU de Saint-Etienne, Hopital Nord
Saint- Etienne, France, 42055
CH de St Dié des Vosges
St Dié des Vosges, France, 88187
CHU Toulouse, Hopital de Rangueil
Toulouse, France, 31059
CHU Toulouse, Hopital Larrey
Toulouse, France, 31059
CH Trouville
Trouville, France, 14360
CHU de Nancy, Hopital Brabois
Vandoeuvre les Nancy, France, 54511
Ch St. Nicolas
Verdun, France, 55100
Germany
Universitätsklinikum Aachen
Aachen, Germany, 52074
Praxis Dr. Frieske
Aachen, Germany, 52062
DRK Krankenhaus
Alzey, Germany, 55232
Gemeinschaftspraxis Weiß / Dr. Heesing
Arnsberg, Germany, 59821
Zentralklinikum Bad Berka
Bad Berka, Germany, 99437
Schlaflabor Breisgau
Bad Krozingen, Germany, 79189
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Klinik Lazariterhof
Bad Krozingen, Germany, 79189
Praxis Dr. Bauer
Bad Mergentheim, Germany, 97980
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Oberlausitz-Kliniken gGmbH
Bautzen, Germany, 02625
Kardiologie Brühl
Bergheim, Germany, 50126
Kardiopraxis Rheinberg
Bergisch Gladbach, Germany, 51465
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Charité Campus Mitte CCM- Schlafmedizinisches Zentrum
Berlin, Germany, 10117
Evangelische Lungenfachklinik Buch
Berlin, Germany, 13125
Praxis Westend
Berlin, Germany, 14050
Charité Campus Mitte - Kardiologie
Berlin, Germany, 10117
Jüdisches Krankenhaus Berlin
Berlin, Germany, 13347
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
POLIKUM Friedenau
Berlin, Germany, 12157
Gemeinschaftspraxis Groß-Ziethener Chaussee
Berlin, Germany, 12355
Herzzentrum Brandenburg
Bernau, Germany, 16321
Praxis für Lunge, Herz und Schlaf
Bielefeld, Germany, 33617
St.-Josephs-Hospital
Bochum, Germany, 44791
Universitätsklinikum Bergmannsheil
Bochum, Germany, 44789
Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling
Bochum, Germany, 44787
Kardiologische Praxis Dr. Staubach
Bochum, Germany, 44866
Augusta Krankenanstalten Bochum
Bochum, Germany, 44791
Kardiologie Kemnade
Bochum, Germany, 44797
Universitätsklinikum Bonn
Bonn, Germany, 53127
Kardiologische Praxis Marschner
Bonn, Germany, 53225
Helios Klinikum Borna
Borna, Germany, 04552
Gemeinschaftspraxis Kardiologie
Bottrop, Germany, 46236
Klinikum Bremen Ost
Bremen, Germany, 28325
Kardiologie Brühl
Brühl, Germany, 50321
Mediclin Rehazentrum Spreewald
Burg, Germany, 03096
Kardiologische Praxis Dr. Isbruch
Castrop-Rauxel, Germany, 44577
Gemeinschaftspraxis Kardiologie Dr. Becker
Castrop-Rauxel, Germany, 44575
MVZ am Küchwald
Chemnitz, Germany, 09113
Klinikum Coburg GmbH
Coburg, Germany, 96450
Fachkrankenhaus Coswig
Coswig, Germany, 01640
Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin
Cottbus, Germany, 03050
Carl-Thiem-Klinikum gGmbH
Cottbus, Germany, 03042
MECS Cottbus GmbH
Cottbus, Germany, 03050
Kardiologische Praxis Dr. Lodde
Dortmund, Germany, 44147
Kardiologische Praxis Dr. Wetzel
Dortmund, Germany, 44141
Praxis Dr. Hecker
Dortmund, Germany, 44135
Kardiologische Praxis Dr. Dröse
Dortmund, Germany, 44263
Clinical Trial Site Services
Dortmund, Germany, 44141
Kardiologische Praxis Dr. Golling
Dortmund, Germany, 44137
Praxis Dr. Hohensee
Dresden, Germany, 01277
Gemeinschaftspraxis Dres. Schmidt/Gronke
Dresden, Germany, 01219
Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany, 01099
Herzzentrum Universität Dresden
Dresden, Germany, 01307
Gemeinschaftspraxis PD. Dr. Lankisch
Düsseldorf, Germany, 40597
Kardiologische Praxis Dr. Horowitz
Düsseldorf, Germany, 40215
Kardiologische Praxis Dr. Raff
Düsseldorf, Germany, 40237
goMedus Gesundheitszentrum
Düsseldorf, Germany, 40212
Kardiologie Oberkassel
Düsseldorf, Germany, 40545
Evangelisches Krankenhaus
Düsseldorf, Germany, 40217
Florence-Nightingale Krankenhaus
Düsseldorf, Germany, 40489
Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl
Emmendingen, Germany, 79312
Helios Klinikum Erfurt-Schlafmedizin
Erfurt, Germany, 99089
Helios Klinikum Erfurt-Kardiologie
Erfurt, Germany, 99089
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Kardiologische Praxis Dr. Cord Müller
Essen, Germany, 45131
Elisabeth-Krankenhaus Essen
Essen, Germany, 45138
Ruhrlandklinik Essen
Essen, Germany, 45239
Praxis Dr. Tekiyeh
Essen, Germany, 45136
Kardiologische Praxis Prof. Winter
Essen, Germany, 45134
Praxis Dr. Rau
Essen, Germany, 45276
Westdeutsches Herzzentrum, Universitätsklinikum Essen
Essen, Germany, 45122
Kath. Kliniken Essen / Philippusstift
Essen, Germany, 45359
Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
Essen, Germany, 45131
Kardiologie Praxis Dr. Bonnekamp
Essen, Germany, 45136
Gemeinschaftspraxis Dres. Guckenbiehl
Flonheim, Germany, 55237
Kardiologische Praxis Dr. Kruse
Forst, Germany, 03149
CardioVasculäres Centrum Frankfurt
Frankfurt, Germany, 60389
Praxis Dr. Diedrichs
Frechen, Germany, 50226
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Gemeinschaftspraxis Dres. Böhmeke/Schmidt
Gladbeck, Germany, 45964
Kardiologische Praxis Dr. Hug
Günzburg, Germany, 89312
Kardiologische Praxis Gütersloh
Gütersloh, Germany, 33334
Kardiologische Praxis Dr. Arens
Hagen, Germany, 58095
Gemeinschaftspraxis Dres Leischik/Littwitz
Hagen, Germany, 58095
Internistenpraxis Alstertal Hamburg
Hamburg, Germany, 22399
Asklepios Klinik Barmbek
Hamburg, Germany, 22291
Gemeinschaftspraxis Dres. Subin/Lutter
Hamburg, Germany, 20095
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
MH Hannover
Hannover, Germany, 30625
Klinikum Hannover Oststadt-Heidehaus
Hannover, Germany, 30659
Siloah Krankenhaus
Hannover, Germany, 30449
Kardiologische Praxis Dr. Cierpka
Hannover, Germany, 30159
Praxis Dr. Hötte
Hannover, Germany, 30449
Kardiologische Praxis Dr. Hartung
Hannover, Germany, 30559
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Praxis Dr. Durak
Heidelberg, Germany, 69115
Lungenklinik Hemer
Hemer, Germany, 58675
Gemeinschaftspraxis Dr. Bruch
Herne, Germany, 44629
Kardiologische Praxis Dr. Furche
Herne, Germany, 44623
Kardiologische Praxis Dr. Schlichting
Herne, Germany, 44649
Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet
Herne, Germany, 44651
St. Elisabeth-Hospital Herten gGmbH
Herten, Germany, 45699
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Cardiopraxis Ingelheim
Ingelheim, Germany, 55218
Gemeinschaftspraxis Dres. Dobler/Turin
Karlstadt, Germany, 97753
Ambulantes Herzzentrum Kassel
Kassel, Germany, 34121
Kardiologische Praxis Dr. Siegfried Frickel
Kempen, Germany, 47906
Helios Klinikum Krefeld
Krefeld, Germany, 47805
Praxis Dr. Krater
Krefeld, Germany, 47799
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
Köln, Germany, 51105
Malteser Krankenhaus St.Hildegardis
Köln, Germany, 50931
Praxis Dr. Anselm Bäumer
Köln, Germany, 51065
Kardiologische Praxis Dr. Fritsch
Köln, Germany, 50737
Prof. Franzen Institut
Köln, Germany, 50937
St.-Vinzenz Hospital
Köln, Germany, 50733
Klinikum Dahme-Spreewald GmbH
Königs Wusterhausen, Germany, 15711
Universitätsklinikum Leipzig-Herzzentrum
Leipzig, Germany, 04289
Helios Krankenhaus Leisnig
Leisnig, Germany, 04703
Gemeinschaftspraxis Dr. Hilgedieck/Sava
Lengerich, Germany, 49525
Kardiologische Praxis Dr. Faber
Lindlar, Germany, 51784
Ärztezentrum Holthausen-Biene
Lingen, Germany, 49808
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor
Lübeck, Germany, 23538
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
Lübeck, Germany, 23538
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55101
Cardiopraxis Ingelheim
Mainz, Germany, 55116
Gemeinschaftspraxis für Herz & Gefäße
Mannheim, Germany, 68161
Gemeinschaftspraxis Dres. Brandt / Jakobs
Mannheim, Germany, 68305
Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
Mannheim, Germany, 68161
Universitätsklinik Mannheim-Kardiologie
Mannheim, Germany, 68167
Universitätsklinikum Mannheim-Schlafmedizin
Mannheim, Germany, 68135
Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
Marburg, Germany, 35043
Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin
Marburg, Germany, 35033
Praxis Dr. Schnabel
Meissen, Germany, 01662
Gemeinschaftspraxis Dr. Jocham
Memmingen, Germany, 87700
Praxis Für Kardiologie Dr. med. Menz
Menden, Germany, 58706
Krankenhaus Bethanien
Moers, Germany, 47441
Kardiologische Praxis Dr. Schön
Mühldorf, Germany, 84453
Evangelisches Krankenhaus Mülheim
Mülheim an der Ruhr, Germany, 45468
Kardiologie am Rotkreuzplatz
München, Germany, 80634
Kardiologische Praxis Dr. Herholz
München, Germany, 80809
Lungenärzte am Rotkreuzplatz
München, Germany, 80634
Gemeinschaftspraxis Dres. Wauer / Windstetter
München, Germany, 80799
Praxis Dres. Böhme/Linke
München, Germany, 81667
Klinik Augustinum München
München, Germany, 81375
Kardiologische Praxis Dr. Muradi
Münster, Germany, 29633
Praxis für Kardiologie Dr. med. Hewing
Münster, Germany, 48151
Universitätsklinikum Münster
Münster, Germany, 48149
Lukaskrankenhaus GmbH
Neuss, Germany, 41464
Kardiologische Praxis Nienburg
Nienburg, Germany, 31582
Klinikum Nürnberg Nord
Nürnberg, Germany, 90419
Klinikum Nürnberg Süd
Nürnberg, Germany, 90471
Kardiologische Praxis Dr. Gumbrecht
Ochtrup, Germany, 48607
Kardiologische Praxis Dr. Wiethölter
Radebeul, Germany, 01445
Praxis Dr. Fröhlich
Ratingen, Germany, 40885
Praxis für Kardiologie Ratingen
Ratingen, Germany, 40878
DRK Krankenhaus Mölln-Ratzeburg
Ratzeburg, Germany, 23909
Ambulantes Cardiovaskuläres Centrum
Ravensburg, Germany, 88212
Gemeinschaftspraxis Dr. Weber/Dr. Feja
Recklinghausen, Germany, 45657
Knappschafts-Krankenhaus Recklinghausen
Recklinghausen, Germany, 45657
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Praxis Dr. Hein
Reinbek, Germany, 21465
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, Germany, 21465
Praxis Dr. Kestermann
Rheine, Germany, 48431
Praxis Dr. Nebel
Rheine, Germany, 48429
Kardiologische Praxis Dr. Heinze
Schwerte, Germany, 58239
Praxis Dr. Ebeling
Schönefeld, Germany, 12529
Praxisgemeinschaft Cardio-Soest
Soest, Germany, 59494
Facharztzentrum Sonneberg
Sonneberg, Germany, 96515
Kreiskrankenhaus Stollberg GmbH
Stollberg, Germany, 09366
Klinikum Uelzen GmbH
Uelzen, Germany, 29525
Herzklinik Ulm Dr. Haerer und Partner
Ulm, Germany, 89077
Zentrum für Innere Medizin Uni Ulm
Ulm, Germany, 89081
Katharinen Hospital Unna
Unna, Germany, 59423
Kardiologische Praxis Dr. Burkhard-Meier
Viersen, Germany, 41747
Praxis Dr. Gerritsen
Waldkraiburg, Germany, 84478
Fachkliniken Wangen
Wangen, Germany, 88239
Stiftungsklinik Weißenhorn
Weißenhorn, Germany, 89264
Kardiologische Praxis Dr. Vrettos
Witten, Germany, 58452
Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
Worms, Germany, 67547
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Missionsärztliche Klinik Würzburg
Würzburg, Germany, 97074
Evangel. Khs Zweibrücken
Zweibrücken, Germany, 66482
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Stavanger AS
Stavanger, Norway, 4011
Sweden
Sahlgrenska University Hospital / Östra
Göteborg, Sweden, 41345
Sahlgrenska University Hospital / Östra
Göteborg, Sweden, U/6 85
Specialistläkarmottagning Residenset AB
Jönköping, Sweden, 55316
Skaraborgs Hospital
Lidköping, Sweden, 53185
Linköping University Hospital
Linköping, Sweden, 58185
Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland, 6903
Cardiocentro Ticino
Lugano, Switzerland, 6900
United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom, Calow S44 5DX
Castle Hill Hospital
Cottingham-East Yorkshire, United Kingdom, HU165JQ
Brompton Hospital
London, United Kingdom, SW36NP
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Musgrove Park Hospital
Taunton, United Kingdom, TA1 5DA
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
ResMed
The Clinical Research Institute GmbH
Investigators
Principal Investigator: Helmut Teschler, Prof. Universitätsklinikum Essen
Principal Investigator: Martin Cowie, Prof. National Heart and Lung Institute (NHLI) Brompton Hospital, London
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00733343     History of Changes
Other Study ID Numbers: 01, ISRCTN19572887
Study First Received: February 14, 2008
Last Updated: September 18, 2014
Health Authority: Denmark: Ethics Committee
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: National Health Service
Norway:National Committee for Medical and Health Research Ethics
Sweden: Regional Ethical Review Board
Australia: Human Research Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Finland: Ethics Committee
Switzerland: Comitato Etico Cantone Tizino

Keywords provided by ResMed:
heart failure
sleep disordered breathing
sleep apnea
left ventricular systolic dysfunction
SBAS
HF

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014