Clinical trial NCT00733343: Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
Official title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Sleep Disordered Breathing
Keywords: heart failure (HF)
sleep disordered breathing (SDB)
sleep apnea
left ventricular systolic dysfunction
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: CRI-The Clinical Research Institute GmbH
First posted: 2008-08-13
Enrollment: 1325
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
timeFrame: time to first event, assessed for up to 70 weeks
measure: Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
timeFrame: time to first event, assessed for up to 70 weeks
measure: All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation
timeFrame: time to first event, assessed for up to 70 weeks
Secondary outcomes:
measure: Death From Any Cause
timeFrame: the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks
measure: Non-cardiovascular Death
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Cardiovascular Death
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: 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
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Age Baseline
timeFrame: 1 x at Baseline
measure: Body Weight Baseline
timeFrame: 1 x at baseline
measure: Body Mass Index (BMI) Baseline
timeFrame: 1 x baseline
measure: Left Ventricular Ejection Fraction at Baseline
timeFrame: 1x at baseline
measure: Blood Pressure Systolic Baseline
timeFrame: 1 x at baseline
measure: Blood Pressure Diastolic Baseline
timeFrame: 1 x at baseline
measure: Hemoglobine Baseline
timeFrame: 1 x at baseline
measure: Creatinine Baseline
timeFrame: 1 x at baseline
measure: Glomerular Filtration Rate Baseline
timeFrame: 1 x at baseline
measure: 6-Min Walk Distance
timeFrame: 1 x at baseline
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 1 x at baseline
measure: Apnoea-Hypopnea-Index (AHI) at Baseline
timeFrame: 1 x at baseline
measure: Central Apnoea Index/Total AHI
timeFrame: 1 x at baseline
measure: Central AHI/Total AHI at Baseline
timeFrame: 1 x at baseline
measure: Oxygen Desaturation Index (ODI) at Baseline
timeFrame: 1 x at baseline
measure: Oxygen Saturation Baseline
timeFrame: 1 x at baseline
measure: Time With Oxygen Saturation Below 90%
timeFrame: 1 x at baseline
measure: Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Changes in NYHA Classification as Compared to Baseline
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Changes in QoL (Minnesota) as Compared to Baseline
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Changes in Renal Function (Based on Serum Creatinine) as Compared to Baseline
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Changes of AHI and Oxygen Desaturation Index Compared to Baseline
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Atrial Fibrillation at Follow-up Visits
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Number and Cost of Hospitalisations (With Tariff/DRG, Diagnoses and Procedures for Calculating DRG or Length of Stay and Level of Care Provided)
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Difference in Cost of Resources Consumed
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Incremental Cost-efficacy Ratio
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
measure: Incremental Cost-utility Ratio
timeFrame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Rivercity Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Melbourne Sleep Disorders Centre
state: Victoria
city: Melbourne
country: Australia
facility: St Vincents and Mercy Private Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital (CVS)
state: Western Australia
city: Brno
country: Czechia
facility: St. Anne's University Hospital BRNO
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Glostrup
country: Denmark
facility: Dansk Center For Søvnmedicin
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Århus C
country: Denmark
facility: Århus Universitets Hospital
city: Århus N
country: Denmark
facility: Århus Universitets Hospital Skejby
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Unesta Research Centre
city: Tampere
country: Finland
facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
city: Amneville
country: France
facility: Cardiologist Dr. Papola
city: Angers
country: France
facility: CHU Angers
city: Antibes
country: France
facility: Centre Hospitalier d'Antibes Juan-les-Pins
city: Antony
country: France
facility: Hopital Prive d'Antony
city: Belfort
country: France
facility: CH Belfort
city: Besancon
country: France
facility: CH de Besancon
city: Beziers
country: France
facility: Centre Hospitalier de Béziers
city: Bordeaux
country: France
facility: Clinique du Tondu
city: Bordeaux
country: France
facility: Hôpital St. André
city: Bordeaux
country: France
facility: Praxis Cardiologique Dr. Puel
city: Bordeaux
country: France
facility: Praxis Cardiologique Dr. Wickers
city: Bordeaux
country: France
facility: CHU Bordeaux, Hopital Pellegrin
city: Caen Cedex
country: France
facility: CHU de Caen
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Echirolles
country: France
facility: Hôpital Sud
city: Forbach
country: France
facility: CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology
city: Forbach
country: France
facility: CH de Forbach-Cardiology
city: Grenoble
country: France
facility: Clinique Mutualiste des Eaux Claires
city: Grenoble
country: France
facility: CHU Grenoble, Hopital Michallon
city: Haguenau
country: France
facility: CH Haguenau
city: L'Union
country: France
facility: Clinique de L'Union
city: Lille
country: France
facility: CHU Lille- Hopital Cardiologique
city: Lille
country: France
facility: CHU Lille-Sleep medicine
city: Lille
country: France
facility: Polyclinique La Louviere
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hopital de la Croix-Rousse
city: Metz
country: France
facility: CHR Metz, Hôpital de Bon-Secours
city: Montbeliard
country: France
facility: CH Montbeliard
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montreuil
country: France
facility: CH Intercommunal André Grégoire
city: Mulhouse
country: France
facility: CH de Mulhouse, Hopital Emile Muller
city: Ollioules
country: France
facility: Clinique les Fleurs
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: CHU Tenon
city: Pessac
country: France
facility: CHU de Bordeaux, Hopital Haut Leveque
city: Poitiers
country: France
facility: CHU de Poitiers
city: Pont-à-mousson
country: France
facility: Cabinet de cardiologie
city: Pontoise
country: France
facility: CH Rene Dubos
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
city: Rouen
country: France
facility: CHU de Rouen, Hopital de Bois Guillaume
city: Saint Avold
country: France
facility: CH Lemire - St Avold
city: Saint Louis
country: France
facility: Clinique des Trois Frontières
city: Saint- Etienne
country: France
facility: CHU de Saint-Etienne, Hopital Nord
city: St Dié des Vosges
country: France
facility: CH de St Dié des Vosges
city: Toulouse
country: France
facility: CHU Toulouse, Hopital de Rangueil
city: Toulouse
country: France
facility: CHU Toulouse, Hopital Larrey
city: Trouville
country: France
facility: CH Trouville
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy, Hopital Brabois
city: Verdun
country: France
facility: Ch St. Nicolas
city: Ingelheim Am Rhein
country: Germany
facility: Cardiopraxis Ingelheim
state: Rheinland-Pfalz
city: Aachen
country: Germany
facility: Praxis Dr. Frieske
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Alzey
country: Germany
facility: DRK Krankenhaus
city: Arnsberg
country: Germany
facility: Gemeinschaftspraxis Weiß / Dr. Heesing
city: Bad Berka
country: Germany
facility: Zentralklinikum Bad Berka
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Krozingen
country: Germany
facility: Klinik Lazariterhof
city: Bad Krozingen
country: Germany
facility: Schlaflabor Breisgau
city: Bad Mergentheim
country: Germany
facility: Praxis Dr. Bauer
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bautzen
country: Germany
facility: Oberlausitz-Kliniken gGmbH
city: Bergheim
country: Germany
facility: Kardiologie Brühl
city: Bergisch Gladbach
country: Germany
facility: Kardiopraxis Rheinberg
city: Berlin
country: Germany
facility: Charité Campus Mitte - Kardiologie
city: Berlin
country: Germany
facility: Charité Campus Mitte CCM- Schlafmedizinisches Zentrum
city: Berlin
country: Germany
facility: POLIKUM Friedenau
city: Berlin
country: Germany
facility: Gemeinschaftspraxis Groß-Ziethener Chaussee
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Evangelische Lungenfachklinik Buch
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Praxis Westend
city: Bernau
country: Germany
facility: Herzzentrum Brandenburg
city: Bielefeld
country: Germany
facility: Praxis für Lunge, Herz und Schlaf
city: Bochum
country: Germany
facility: Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling
city: Bochum
country: Germany
facility: Universitätsklinikum Bergmannsheil
city: Bochum
country: Germany
facility: Augusta Krankenanstalten Bochum
city: Bochum
country: Germany
facility: St.-Josephs-Hospital
city: Bochum
country: Germany
facility: Kardiologie Kemnade
city: Bochum
country: Germany
facility: Kardiologische Praxis Dr. Staubach
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bonn
country: Germany
facility: Kardiologische Praxis Marschner
city: Borna
country: Germany
facility: Helios Klinikum Borna
city: Bottrop
country: Germany
facility: Gemeinschaftspraxis Kardiologie
city: Bremen
country: Germany
facility: Klinikum Bremen Ost
city: Brühl
country: Germany
facility: Kardiologie Brühl
city: Burg
country: Germany
facility: Mediclin Rehazentrum Spreewald
city: Castrop-Rauxel
country: Germany
facility: Gemeinschaftspraxis Kardiologie Dr. Becker
city: Castrop-Rauxel
country: Germany
facility: Kardiologische Praxis Dr. Isbruch
city: Chemnitz
country: Germany
facility: MVZ am Küchwald
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum gGmbH
city: Cottbus
country: Germany
facility: Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin
city: Cottbus
country: Germany
facility: MECS Cottbus GmbH
city: Dortmund
country: Germany
facility: Praxis Dr. Hecker
city: Dortmund
country: Germany
facility: Kardiologische Praxis Dr. Golling
city: Dortmund
country: Germany
facility: Clinical Trial Site Services
city: Dortmund
country: Germany
facility: Kardiologische Praxis Dr. Wetzel
city: Dortmund
country: Germany
facility: Kardiologische Praxis Dr. Lodde
city: Dortmund
country: Germany
facility: Kardiologische Praxis Dr. Dröse
city: Dresden
country: Germany
facility: Facharztzentrum Dresden-Neustadt GbR
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dres. Schmidt/Gronke
city: Dresden
country: Germany
facility: Praxis Dr. Hohensee
city: Dresden
country: Germany
facility: Herzzentrum Universität Dresden
city: Düsseldorf
country: Germany
facility: goMedus Gesundheitszentrum
city: Düsseldorf
country: Germany
facility: Kardiologische Praxis Dr. Horowitz
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Düsseldorf
country: Germany
facility: Kardiologische Praxis Dr. Raff
city: Düsseldorf
country: Germany
facility: Florence-Nightingale Krankenhaus
city: Düsseldorf
country: Germany
facility: Kardiologie Oberkassel
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis PD. Dr. Lankisch
city: Emmendingen
country: Germany
facility: Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt-Kardiologie
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt-Schlafmedizin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum, Universitätsklinikum Essen
city: Essen
country: Germany
facility: Kardiologische Praxis Dr. Cord Müller
city: Essen
country: Germany
facility: Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
city: Essen
country: Germany
facility: Kardiologische Praxis Prof. Winter
city: Essen
country: Germany
facility: Kardiologie Praxis Dr. Bonnekamp
city: Essen
country: Germany
facility: Praxis Dr. Tekiyeh
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
city: Essen
country: Germany
facility: Praxis Dr. Rau
city: Essen
country: Germany
facility: Kath. Kliniken Essen / Philippusstift
city: Flonheim
country: Germany
facility: Gemeinschaftspraxis Dres. Guckenbiehl
city: Forst
country: Germany
facility: Kardiologische Praxis Dr. Kruse
city: Frankfurt
country: Germany
facility: CardioVasculäres Centrum Frankfurt
city: Frechen
country: Germany
facility: Praxis Dr. Diedrichs
city: Freiburg im Breisgau
country: Germany
facility: Universitaetsklinikum Freiburg
city: Gladbeck
country: Germany
facility: Gemeinschaftspraxis Dres. Böhmeke/Schmidt
city: Günzburg
country: Germany
facility: Kardiologische Praxis Dr. Hug
city: Gütersloh
country: Germany
facility: Kardiologische Praxis Gütersloh
city: Hagen
country: Germany
facility: Gemeinschaftspraxis Dres Leischik/Littwitz
city: Hagen
country: Germany
facility: Kardiologische Praxis Dr. Arens
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis Dres. Subin/Lutter
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hamburg
country: Germany
facility: Internistenpraxis Alstertal Hamburg
city: Hannover
country: Germany
facility: Kardiologische Praxis Dr. Cierpka
city: Hannover
country: Germany
facility: Praxis Dr. Hötte
city: Hannover
country: Germany
facility: Siloah Krankenhaus
city: Hannover
country: Germany
facility: Kardiologische Praxis Dr. Hartung
city: Hannover
country: Germany
facility: MH Hannover
city: Hannover
country: Germany
facility: Klinikum Hannover Oststadt-Heidehaus
city: Heidelberg
country: Germany
facility: Praxis Dr. Durak
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Herne
country: Germany
facility: Kardiologische Praxis Dr. Furche
city: Herne
country: Germany
facility: Gemeinschaftspraxis Dr. Bruch
city: Herne
country: Germany
facility: Kardiologische Praxis Dr. Schlichting
city: Herne
country: Germany
facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet
city: Herten
country: Germany
facility: St. Elisabeth-Hospital Herten gGmbH
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Karlstadt
country: Germany
facility: Gemeinschaftspraxis Dres. Dobler/Turin
city: Kassel
country: Germany
facility: Ambulantes Herzzentrum Kassel
city: Kempen
country: Germany
facility: Kardiologische Praxis Dr. Siegfried Frickel
city: Krefeld
country: Germany
facility: Praxis Dr. Krater
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
city: Köln
country: Germany
facility: St.-Vinzenz Hospital
city: Köln
country: Germany
facility: Kardiologische Praxis Dr. Fritsch
city: Köln
country: Germany
facility: Malteser Krankenhaus St.Hildegardis
city: Köln
country: Germany
facility: Prof. Franzen Institut
city: Köln
country: Germany
facility: Praxis Dr. Anselm Bäumer
city: Köln
country: Germany
facility: Gemeinschaftspraxis Dres. Gysan/Heinzler/May
city: Königs Wusterhausen
country: Germany
facility: Klinikum Dahme-Spreewald GmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig-Herzzentrum
city: Leisnig
country: Germany
facility: Helios Krankenhaus Leisnig
city: Lengerich
country: Germany
facility: Gemeinschaftspraxis Dr. Hilgedieck/Sava
city: Lindlar
country: Germany
facility: Kardiologische Praxis Dr. Faber
city: Lingen
country: Germany
facility: Ärztezentrum Holthausen-Biene
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität Mainz
city: Mainz
country: Germany
facility: Cardiopraxis Ingelheim
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim-Schlafmedizin
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis für Herz & Gefäße
city: Mannheim
country: Germany
facility: Universitätsklinik Mannheim-Kardiologie
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis Dres. Brandt / Jakobs
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
city: Meissen
country: Germany
facility: Praxis Dr. Schnabel
city: Memmingen
country: Germany
facility: Gemeinschaftspraxis Dr. Jocham
city: Menden
country: Germany
facility: Praxis Für Kardiologie Dr. med. Menz
city: Moers
country: Germany
facility: Krankenhaus Bethanien
city: Mühldorf
country: Germany
facility: Kardiologische Praxis Dr. Schön
city: Mülheim an der Ruhr
country: Germany
facility: Evangelisches Krankenhaus Mülheim
city: München
country: Germany
facility: Kardiologie am Rotkreuzplatz
city: München
country: Germany
facility: Lungenärzte am Rotkreuzplatz
city: München
country: Germany
facility: Gemeinschaftspraxis Dres. Wauer / Windstetter
city: München
country: Germany
facility: Kardiologische Praxis Dr. Herholz
city: München
country: Germany
facility: Klinik Augustinum München
city: München
country: Germany
facility: Praxis Dres. Böhme/Linke
city: Münster
country: Germany
facility: Kardiologische Praxis Dr. Muradi
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Münster
country: Germany
facility: Praxis für Kardiologie Dr. med. Hewing
city: Neuss
country: Germany
facility: Lukaskrankenhaus GmbH
city: Nienburg
country: Germany
facility: Kardiologische Praxis Nienburg
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Ochtrup
country: Germany
facility: Kardiologische Praxis Dr. Gumbrecht
city: Radebeul
country: Germany
facility: Kardiologische Praxis Dr. Wiethölter
city: Ratingen
country: Germany
facility: Praxis für Kardiologie Ratingen
city: Ratingen
country: Germany
facility: Praxis Dr. Fröhlich
city: Ratzeburg
country: Germany
facility: DRK Krankenhaus Mölln-Ratzeburg
city: Ravensburg
country: Germany
facility: Ambulantes Cardiovaskuläres Centrum
city: Recklinghausen
country: Germany
facility: Gemeinschaftspraxis Dr. Weber/Dr. Feja
city: Recklinghausen
country: Germany
facility: Knappschafts-Krankenhaus Recklinghausen
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek St. Adolf-Stift
city: Reinbek
country: Germany
facility: Praxis Dr. Hein
city: Rheine
country: Germany
facility: Praxis Dr. Nebel
city: Rheine
country: Germany
facility: Praxis Dr. Kestermann
city: Schwerte
country: Germany
facility: Kardiologische Praxis Dr. Heinze
city: Schönefeld
country: Germany
facility: Praxis Dr. Ebeling
city: Soest
country: Germany
facility: Praxisgemeinschaft Cardio-Soest
city: Sonneberg
country: Germany
facility: Facharztzentrum Sonneberg
city: Stollberg
country: Germany
facility: Kreiskrankenhaus Stollberg GmbH
city: Uelzen
country: Germany
facility: Klinikum Uelzen GmbH
city: Ulm
country: Germany
facility: Herzklinik Ulm Dr. Haerer und Partner
city: Ulm
country: Germany
facility: Zentrum für Innere Medizin Uni Ulm
city: Unna
country: Germany
facility: Katharinen Hospital Unna
city: Viersen
country: Germany
facility: Kardiologische Praxis Dr. Burkhard-Meier
city: Waldkraiburg
country: Germany
facility: Praxis Dr. Gerritsen
city: Wangen
country: Germany
facility: Fachkliniken Wangen
city: Weißenhorn
country: Germany
facility: Stiftungsklinik Weißenhorn
city: Witten
country: Germany
facility: Kardiologische Praxis Dr. Vrettos
city: Worms
country: Germany
facility: Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
city: Würzburg
country: Germany
facility: Missionsärztliche Klinik Würzburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zweibrücken
country: Germany
facility: Evangel. Khs Zweibrücken
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Oslo
country: Norway
facility: Ullevål University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Stavanger
country: Norway
facility: Stavanger AS
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital / Östra
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital / Östra
city: Jönköping
country: Sweden
facility: Specialistläkarmottagning Residenset AB
city: Lidköping
country: Sweden
facility: Skaraborgs Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
city: London
country: United Kingdom
facility: Brompton Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals NHS Trust
Study officials:
affiliation: Universitätsklinikum Essen
name: Helmut Teschler, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Heart and Lung Institute (NHLI) Brompton Hospital, London
name: Martin Cowie, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.