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

Primary Purpose

Heart Failure, Sleep Disordered Breathing

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Europe: AutoSet CS (USA: VPAP Adapt SV)
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure (HF), sleep disordered breathing (SDB), sleep apnea, left ventricular systolic dysfunction

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Hospital
  • Rivercity Private Hospital
  • Royal Adelaide Hospital
  • Melbourne Sleep Disorders Centre
  • St Vincents and Mercy Private Hospital
  • Hollywood Private Hospital (CVS)
  • St. Anne's University Hospital BRNO
  • Rigshospitalet
  • Bispebjerg Hospital
  • Dansk Center For Søvnmedicin
  • Glostrup Hospital
  • Århus Universitets Hospital
  • Århus Universitets Hospital Skejby
  • Helsinki University Hospital
  • Unesta Research Centre
  • Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
  • Cardiologist Dr. Papola
  • CHU Angers
  • Centre Hospitalier d'Antibes Juan-les-Pins
  • Hopital Prive d'Antony
  • CH Belfort
  • CH de Besancon
  • Centre Hospitalier de Béziers
  • Clinique du Tondu
  • Hôpital St. André
  • Praxis Cardiologique Dr. Puel
  • Praxis Cardiologique Dr. Wickers
  • CHU Bordeaux, Hopital Pellegrin
  • CHU de Caen
  • Centre Hospitalier de Cannes
  • Hopital Henri Mondor
  • Hôpital Sud
  • CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology
  • CH de Forbach-Cardiology
  • Clinique Mutualiste des Eaux Claires
  • CHU Grenoble, Hopital Michallon
  • CH Haguenau
  • Clinique de L'Union
  • CHU Lille- Hopital Cardiologique
  • CHU Lille-Sleep medicine
  • Polyclinique La Louviere
  • Hospices Civils de Lyon, Hopital de la Croix-Rousse
  • CHR Metz, Hôpital de Bon-Secours
  • CH Montbeliard
  • CHU de Montpellier
  • CH Intercommunal André Grégoire
  • CH de Mulhouse, Hopital Emile Muller
  • Clinique les Fleurs
  • Hôpital Bichat
  • CHU Tenon
  • CHU de Bordeaux, Hopital Haut Leveque
  • CHU de Poitiers
  • Cabinet de cardiologie
  • CH Rene Dubos
  • Polyclinique Saint-Laurent
  • CHU de Rouen, Hopital de Bois Guillaume
  • CH Lemire - St Avold
  • Clinique des Trois Frontières
  • CHU de Saint-Etienne, Hopital Nord
  • CH de St Dié des Vosges
  • CHU Toulouse, Hopital de Rangueil
  • CHU Toulouse, Hopital Larrey
  • CH Trouville
  • CHU de Nancy, Hopital Brabois
  • Ch St. Nicolas
  • Cardiopraxis Ingelheim
  • Praxis Dr. Frieske
  • Universitätsklinikum Aachen
  • DRK Krankenhaus
  • Gemeinschaftspraxis Weiß / Dr. Heesing
  • Zentralklinikum Bad Berka
  • Herzzentrum Bad Krozingen
  • Klinik Lazariterhof
  • Schlaflabor Breisgau
  • Praxis Dr. Bauer
  • Herz- und Diabeteszentrum NRW
  • Oberlausitz-Kliniken gGmbH
  • Kardiologie Brühl
  • Kardiopraxis Rheinberg
  • Charité Campus Mitte - Kardiologie
  • Charité Campus Mitte CCM- Schlafmedizinisches Zentrum
  • POLIKUM Friedenau
  • Gemeinschaftspraxis Groß-Ziethener Chaussee
  • Unfallkrankenhaus Berlin
  • Evangelische Lungenfachklinik Buch
  • Jüdisches Krankenhaus Berlin
  • Charité Campus Virchow Klinikum
  • Praxis Westend
  • Herzzentrum Brandenburg
  • Praxis für Lunge, Herz und Schlaf
  • Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling
  • Universitätsklinikum Bergmannsheil
  • Augusta Krankenanstalten Bochum
  • St.-Josephs-Hospital
  • Kardiologie Kemnade
  • Kardiologische Praxis Dr. Staubach
  • Universitätsklinikum Bonn
  • Kardiologische Praxis Marschner
  • Helios Klinikum Borna
  • Gemeinschaftspraxis Kardiologie
  • Klinikum Bremen Ost
  • Kardiologie Brühl
  • Mediclin Rehazentrum Spreewald
  • Gemeinschaftspraxis Kardiologie Dr. Becker
  • Kardiologische Praxis Dr. Isbruch
  • MVZ am Küchwald
  • Klinikum Coburg GmbH
  • Fachkrankenhaus Coswig
  • Carl-Thiem-Klinikum gGmbH
  • Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin
  • MECS Cottbus GmbH
  • Praxis Dr. Hecker
  • Kardiologische Praxis Dr. Golling
  • Clinical Trial Site Services
  • Kardiologische Praxis Dr. Wetzel
  • Kardiologische Praxis Dr. Lodde
  • Kardiologische Praxis Dr. Dröse
  • Facharztzentrum Dresden-Neustadt GbR
  • Gemeinschaftspraxis Dres. Schmidt/Gronke
  • Praxis Dr. Hohensee
  • Herzzentrum Universität Dresden
  • goMedus Gesundheitszentrum
  • Kardiologische Praxis Dr. Horowitz
  • Evangelisches Krankenhaus
  • Kardiologische Praxis Dr. Raff
  • Florence-Nightingale Krankenhaus
  • Kardiologie Oberkassel
  • Gemeinschaftspraxis PD. Dr. Lankisch
  • Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl
  • Helios Klinikum Erfurt-Kardiologie
  • Helios Klinikum Erfurt-Schlafmedizin
  • Universitätsklinikum Erlangen
  • Westdeutsches Herzzentrum, Universitätsklinikum Essen
  • Kardiologische Praxis Dr. Cord Müller
  • Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
  • Kardiologische Praxis Prof. Winter
  • Kardiologie Praxis Dr. Bonnekamp
  • Praxis Dr. Tekiyeh
  • Elisabeth-Krankenhaus Essen
  • Ruhrlandklinik Essen
  • Praxis Dr. Rau
  • Kath. Kliniken Essen / Philippusstift
  • Gemeinschaftspraxis Dres. Guckenbiehl
  • Kardiologische Praxis Dr. Kruse
  • CardioVasculäres Centrum Frankfurt
  • Praxis Dr. Diedrichs
  • Universitaetsklinikum Freiburg
  • Gemeinschaftspraxis Dres. Böhmeke/Schmidt
  • Kardiologische Praxis Dr. Hug
  • Kardiologische Praxis Gütersloh
  • Gemeinschaftspraxis Dres Leischik/Littwitz
  • Kardiologische Praxis Dr. Arens
  • Gemeinschaftspraxis Dres. Subin/Lutter
  • Universitätsklinikum Hamburg-Eppendorf
  • Asklepios Klinik Barmbek
  • Internistenpraxis Alstertal Hamburg
  • Kardiologische Praxis Dr. Cierpka
  • Praxis Dr. Hötte
  • Siloah Krankenhaus
  • Kardiologische Praxis Dr. Hartung
  • MH Hannover
  • Klinikum Hannover Oststadt-Heidehaus
  • Praxis Dr. Durak
  • Universitätsklinikum Heidelberg
  • Thoraxklinik Heidelberg gGmbH
  • Lungenklinik Hemer
  • Kardiologische Praxis Dr. Furche
  • Gemeinschaftspraxis Dr. Bruch
  • Kardiologische Praxis Dr. Schlichting
  • Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet
  • St. Elisabeth-Hospital Herten gGmbH
  • Lungenfachklinik Immenhausen
  • Gemeinschaftspraxis Dres. Dobler/Turin
  • Ambulantes Herzzentrum Kassel
  • Kardiologische Praxis Dr. Siegfried Frickel
  • Praxis Dr. Krater
  • Helios Klinikum Krefeld
  • St.-Vinzenz Hospital
  • Kardiologische Praxis Dr. Fritsch
  • Malteser Krankenhaus St.Hildegardis
  • Prof. Franzen Institut
  • Praxis Dr. Anselm Bäumer
  • Gemeinschaftspraxis Dres. Gysan/Heinzler/May
  • Klinikum Dahme-Spreewald GmbH
  • Universitätsklinikum Leipzig-Herzzentrum
  • Helios Krankenhaus Leisnig
  • Gemeinschaftspraxis Dr. Hilgedieck/Sava
  • Kardiologische Praxis Dr. Faber
  • Ärztezentrum Holthausen-Biene
  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor
  • Klinikum der Johannes Gutenberg-Universität Mainz
  • Cardiopraxis Ingelheim
  • Universitätsklinikum Mannheim-Schlafmedizin
  • Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
  • Gemeinschaftspraxis für Herz & Gefäße
  • Universitätsklinik Mannheim-Kardiologie
  • Gemeinschaftspraxis Dres. Brandt / Jakobs
  • Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin
  • Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
  • Praxis Dr. Schnabel
  • Gemeinschaftspraxis Dr. Jocham
  • Praxis Für Kardiologie Dr. med. Menz
  • Krankenhaus Bethanien
  • Kardiologische Praxis Dr. Schön
  • Evangelisches Krankenhaus Mülheim
  • Kardiologie am Rotkreuzplatz
  • Lungenärzte am Rotkreuzplatz
  • Gemeinschaftspraxis Dres. Wauer / Windstetter
  • Kardiologische Praxis Dr. Herholz
  • Klinik Augustinum München
  • Praxis Dres. Böhme/Linke
  • Kardiologische Praxis Dr. Muradi
  • Universitätsklinikum Münster
  • Praxis für Kardiologie Dr. med. Hewing
  • Lukaskrankenhaus GmbH
  • Kardiologische Praxis Nienburg
  • Klinikum Nürnberg Nord
  • Klinikum Nürnberg Süd
  • Kardiologische Praxis Dr. Gumbrecht
  • Kardiologische Praxis Dr. Wiethölter
  • Praxis für Kardiologie Ratingen
  • Praxis Dr. Fröhlich
  • DRK Krankenhaus Mölln-Ratzeburg
  • Ambulantes Cardiovaskuläres Centrum
  • Gemeinschaftspraxis Dr. Weber/Dr. Feja
  • Knappschafts-Krankenhaus Recklinghausen
  • Universitätsklinikum Regensburg
  • Krankenhaus Reinbek St. Adolf-Stift
  • Praxis Dr. Hein
  • Praxis Dr. Nebel
  • Praxis Dr. Kestermann
  • Kardiologische Praxis Dr. Heinze
  • Praxis Dr. Ebeling
  • Praxisgemeinschaft Cardio-Soest
  • Facharztzentrum Sonneberg
  • Kreiskrankenhaus Stollberg GmbH
  • Klinikum Uelzen GmbH
  • Herzklinik Ulm Dr. Haerer und Partner
  • Zentrum für Innere Medizin Uni Ulm
  • Katharinen Hospital Unna
  • Kardiologische Praxis Dr. Burkhard-Meier
  • Praxis Dr. Gerritsen
  • Fachkliniken Wangen
  • Stiftungsklinik Weißenhorn
  • Kardiologische Praxis Dr. Vrettos
  • Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
  • Missionsärztliche Klinik Würzburg
  • Universitätsklinikum Würzburg
  • Evangel. Khs Zweibrücken
  • University Medical Center Groningen
  • Ullevål University Hospital
  • Oslo University Hospital, Rikshospitalet
  • Stavanger AS
  • Sahlgrenska University Hospital / Östra
  • Sahlgrenska University Hospital / Östra
  • Specialistläkarmottagning Residenset AB
  • Skaraborgs Hospital
  • Linköping University Hospital
  • Cardiocentro Ticino
  • Ospedale Regionale di Lugano
  • Castle Hill Hospital
  • Chesterfield Royal Hospital
  • Brompton Hospital
  • Freeman Hospital
  • Musgrove Park Hospital
  • Royal Wolverhampton Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Death From Any Cause
Non-cardiovascular Death
Cardiovascular Death
Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
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
First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
Age Baseline
Body Weight Baseline
Body Mass Index (BMI) Baseline
Left Ventricular Ejection Fraction at Baseline
Blood Pressure Systolic Baseline
Blood Pressure Diastolic Baseline
Hemoglobine Baseline
Creatinine Baseline
Glomerular Filtration Rate Baseline
6-Min Walk Distance
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
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.
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.
Central AHI/Total AHI at Baseline
Oxygen Desaturation Index (ODI) at Baseline
Number of oxygen desaturations per hour at baseline
Oxygen Saturation Baseline
Time With Oxygen Saturation Below 90%
Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame
Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause
Changes in NYHA Classification as Compared to Baseline
Changes in QoL (Minnesota) as Compared to Baseline
Changes in Renal Function (Based on Serum Creatinine) as Compared to Baseline
Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline
Changes of AHI and Oxygen Desaturation Index Compared to Baseline
AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months
Atrial Fibrillation at Follow-up Visits
Number and Cost of Hospitalisations (With Tariff/DRG, Diagnoses and Procedures for Calculating DRG or Length of Stay and Level of Care Provided)
Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm
Difference in Cost of Resources Consumed
Incremental Cost-efficacy Ratio
Incremental Cost-utility Ratio

Full Information

First Posted
February 14, 2008
Last Updated
April 29, 2020
Sponsor
ResMed
Collaborators
CRI-The Clinical Research Institute GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00733343
Brief Title
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
Acronym
Serve-HF
Official Title
Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
CRI-The Clinical Research Institute GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: all cause mortality or unplanned hospitalisation/prolongation of hospitalisation for worsening heart failure cardiovascular mortality or unplanned hospitalisation/prolongation of hospitalisation for worsening heart failure. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sleep Disordered Breathing
Keywords
heart failure (HF), sleep disordered breathing (SDB), sleep apnea, left ventricular systolic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Intervention Type
Device
Intervention Name(s)
Europe: AutoSet CS (USA: VPAP Adapt SV)
Intervention Description
At least 3 hours average daily usage time
Primary Outcome Measure Information:
Title
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
Title
Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
Time Frame
time to first event, assessed for up to 70 weeks
Title
All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation
Time Frame
time to first event, assessed for up to 70 weeks
Secondary Outcome Measure Information:
Title
Death From Any Cause
Time Frame
the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks
Title
Non-cardiovascular Death
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Cardiovascular Death
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
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
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Age Baseline
Time Frame
1 x at Baseline
Title
Body Weight Baseline
Time Frame
1 x at baseline
Title
Body Mass Index (BMI) Baseline
Time Frame
1 x baseline
Title
Left Ventricular Ejection Fraction at Baseline
Time Frame
1x at baseline
Title
Blood Pressure Systolic Baseline
Time Frame
1 x at baseline
Title
Blood Pressure Diastolic Baseline
Time Frame
1 x at baseline
Title
Hemoglobine Baseline
Time Frame
1 x at baseline
Title
Creatinine Baseline
Time Frame
1 x at baseline
Title
Glomerular Filtration Rate Baseline
Time Frame
1 x at baseline
Title
6-Min Walk Distance
Time Frame
1 x at baseline
Title
Epworth Sleepiness Scale (ESS)
Description
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
Time Frame
1 x at baseline
Title
Apnoea-Hypopnea-Index (AHI) at Baseline
Description
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.
Time Frame
1 x at baseline
Title
Central Apnoea Index/Total AHI
Description
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.
Time Frame
1 x at baseline
Title
Central AHI/Total AHI at Baseline
Time Frame
1 x at baseline
Title
Oxygen Desaturation Index (ODI) at Baseline
Description
Number of oxygen desaturations per hour at baseline
Time Frame
1 x at baseline
Title
Oxygen Saturation Baseline
Time Frame
1 x at baseline
Title
Time With Oxygen Saturation Below 90%
Time Frame
1 x at baseline
Title
Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Changes in NYHA Classification as Compared to Baseline
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Changes in QoL (Minnesota) as Compared to Baseline
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
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, assessed for up to 70 weeks
Title
Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Changes of AHI and Oxygen Desaturation Index Compared to Baseline
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Atrial Fibrillation at Follow-up Visits
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
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
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Difference in Cost of Resources Consumed
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Incremental Cost-efficacy Ratio
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Title
Incremental Cost-utility Ratio
Time Frame
the last follow up or at the last available observation within FU, assessed for up to 70 weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
26886528
Citation
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.
Results Reference
result
PubMed Identifier
27592224
Citation
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.
Results Reference
result
PubMed Identifier
28860264
Citation
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.
Results Reference
result
PubMed Identifier
26888594
Citation
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.
Results Reference
derived
PubMed Identifier
26323938
Citation
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.
Results Reference
derived

Learn more about this trial

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

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