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Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry (SchlaHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500759
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : August 5, 2015
Information provided by (Responsible Party):

Brief Summary:

Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.

For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.

Condition or disease
Congestive Heart Failure Left Ventricular Systolic Dysfunction

Detailed Description:

Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.

Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.

Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.

For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.

Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10775 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
Study Start Date : November 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with Chronic Heart Failure with LVEF ≤ 45% and NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 24 months.

Inclusion Criteria:

  • Patients must be over 18
  • Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines
  • 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
  • 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
  • Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

  • 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
  • CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months
  • Transient ischemic attack (TIA) or Stroke within 3 months
  • Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery
  • Acute myocarditis/pericarditis within 6 months
  • Current CPAP or bilevel therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500759

Hide Hide 199 study locations
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Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne Sleep Disorders Centre
East Melbourne, Victoria, Australia, 3002
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
St Vincents and Mercy Private Hospital
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Hollywood Private Hospital (CVS)
Nedlands, Western Australia, Australia, 6009
Praxis Dr. Frieske
Aachen, Germany, 52062
Universitätsklinikum Aachen
Aachen, Germany, 52074
DRK Krankenhaus
Alzey, Germany, 55232
Gemeinschaftspraxis Weiß/ Dr. Heesing
Arnsberg, Germany, 59821
Zentralklinikum Bad Berka
Bad Berka, Germany, 99437
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Klinik Lazariterhof
Bad Krozingen, Germany, 79189
Praxis Dr. Bauer
Bad Mergentheim, Germany, 97980
Bad Oeynhausen, Germany, 32545
Kardiologische Praxis Dr. Stroh
Bad Wurzach, Germany, 88410
Oberlausitz-Kliniken gGmbH
Bautzen, Germany, 02625
Kardiopraxis Rheinberg
Bergisch Gladbach, Germany, 51465
Charité Campus Mitte CCM
Berlin, Germany, 10117
Charité Campus Mitte
Berlin, Germany, 10117
Praxis Gemeinschaft Frille
Berlin, Germany, 10178
POLIKUM Friedenau
Berlin, Germany, 12157
Gemeinschaftspraxis Groß-Ziethener Chaussee
Berlin, Germany, 12355
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Jüdisches Krankenhaus Berlin
Berlin, Germany, 13347
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Praxis Westend
Berlin, Germany, 14050
Herzzentrum Brandenburg
Bernau, Germany, 16321
Praxis für Lunge,Herz und Schlaf
Bielefeld, Germany, 33617
Kardiologie Gemeinschaftspraxis Dr. Tenholt
Bochum, Germany, 44787
Universitätsklinikum Bergmannsheil
Bochum, Germany, 44789
Augusta Krankenanstalten Bochum
Bochum, Germany, 44791
Bochum, Germany, 44791
Kardiologie Kemnade
Bochum, Germany, 44797
Kardiologische Praxis Dr. Staubach
Bochum, Germany, 44866
Praxis für Kardiologie Bonn
Bonn, Germany, 53127
Universitätsklinikum Bonn
Bonn, Germany, 53127
Kardiologische Praxis Marschner
Bonn, Germany, 53225
Gemeinschaftspraxis Kardiologie
Bottrop, Germany, 46236
Gemeinschaftspraxis Dres. Tinnefeld
Bottrop, Germany, 46240
Kardiologie Bühl
Brühl, Germany, 50321
Mediclin Rehazentrum Spreewald
Burg/Spreewald, Germany, 03096
Gemeinschaftspraxis Kardiologie Dr. Becker
Castrop-Rauxel, Germany, 44575
Kardiologische Praxis Dr. Isbruch
Castrop-Rauxel, Germany, 44577
MVZ am Küchwald
Chemnitz, Germany, 09113
Klinikum Coburg GmbH
Coburg, Germany, 96450
Fachkrankenhaus Coswig
Coswig, Germany, 01640
Carl-Thiem-Klinikum gGmbH
Cottbus, Germany, 03042
Praxis Dr. Hecker
Dortmund, Germany, 44135
Kardiologie - Gemeinschaftspraxis Dortmund
Dortmund, Germany, 44137
Kardiologie-Gemeinschaftspraxis Dortmund
Dortmund, Germany, 44137
Kardiologische Praxis Dr. Golling
Dortmund, Germany, 44137
Klinikum Dortmund gGmbH
Dortmund, Germany, 44137
Clinical Trial Site Services
Dortmund, Germany, 44141
Kardiologische Praxis Dr. Wetzel
Dortmund, Germany, 44141
Kardiologische Praxis Dr. Lodde
Dortmund, Germany, 44147
Kardiologische Praxis Dr. Dröse
Dortmund, Germany, 44263
Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany, 01099
Gemeinschaftpraxis Dres. Schmidt/Gronke
Dresden, Germany, 01219
Praxis Dr. Hohensee
Dresden, Germany, 01277
Herzzentrum Universität Dresden
Dresden, Germany, 01307
Khs Florence-Nightingale
Duesseldorf, Germany, 40489
goMedus Gesundheitszentrum
Düsseldorf, Germany, 40212
Kardiologische Praxis Dr. Horowitz
Düsseldorf, Germany, 40215
Kardiologische Praxis Dr. Raff
Düsseldorf, Germany, 40237
Florence-Nightingale Krankenhaus
Düsseldorf, Germany, 40489
Kardiologie Oberkassel
Düsseldorf, Germany, 40545
Gemeinschaftspraxis PD Dr. Lankisch
Düsseldorf, Germany, 40597
Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl
Emmendingen, Germany, 79312
Helios Klinikum Erfurt-Kardiologie
Erfurt, Germany, 99089
Helios Klinikum Erfurt-Schlafmedizin
Erfurt, Germany, 99089
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Westdeutsches Herzzentrum, Universitätsklinikum Essen
Essen, Germany, 45122
Kardiologische Praxis Dr. Cord Müller
Essen, Germany, 45131
Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
Essen, Germany, 45131
Kardiologische Praxis Prof. Winter
Essen, Germany, 45134
Kardiologie Praxis Dr. Bonnekamp
Essen, Germany, 45136
Praxis Dr. Tekiyeh
Essen, Germany, 45136
Elisabeth-Krankenhaus Essen
Essen, Germany, 45138
Ruhrlandklinik Essen
Essen, Germany, 45239
Praxis Dr. Rau
Essen, Germany, 45276
Kath. Kliniken Essen / Philippusstift
Essen, Germany, 45359
Gemeinschaftspraxis Dres. Guckenbiehl
Flonheim, Germany, 55237
Kardiologische Praxis Dr. Kruse
Forst, Germany, 03149
CardioVasculäres Centrum Frankfurt
Frankfurt, Germany, 60389
Praxis Dr. Diedrichs
Frechen, Germany, 50226
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Gemeinschaftspraxis Dres. Böhmeke/Schmidt
Gladbeck, Germany, 45964
Kardiologische Praxis Dr. Hug
Günzburg, Germany, 89312
Kardiologische Praxis Gütersloh
Gütersloh, Germany, 33330
Gemeinschaftspraxis Dres Leischik/Littwitz
Hagen, Germany, 58095
Kardiologische Praxis Dr. Arens
Hagen, Germany, 58095
Gemeinschaftspraxis Dres. Subin/Lutter
Hamburg, Germany, 20095
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Barmbek
Hamburg, Germany, 22291
Internistenpraxis Alstertal Hamburg
Hamburg, Germany, 22399
Kardiologische Praxis Dr. Schröder
Hamburg, Germany, 22765
Kardiologische Praxis Dr. Cierpka
Hannover, Germany, 30159
Praxis Dr. Hötte
Hannover, Germany, 30449
Siloah Krankenhaus
Hannover, Germany, 30449
Kardiologische Praxis Dr. Hartung
Hannover, Germany, 30559
Heidelberger Praxisklinik für Kardiologie
Heidelberg, Germany, 69115
Praxis Dr. Durak
Heidelberg, Germany, 69115
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Evangelisches Krankenhaus Herne
Herne, Germany, 44623
EvK Herne
Herne, Germany, 44623
Kardiologische Praxis Dr. Furche
Herne, Germany, 44623
Gemeinschaftspraxis Dr. Bruch
Herne, Germany, 44629
Kardiologische Praxis Dr. Schlichting
Herne, Germany, 44649
St. Elisabeth-Hospital Herten gGmbH
Herten, Germany, 45699
Praxis für Innere Medizin/Kardiologie
Hoyerswerda, Germany, 02977
Cardiopraxis Ingelheim
Ingelheim, Germany, 55218
Gemeinschaftspraxis Dres. Dobler/Turin
Karlstadt, Germany, 97753
Ambulantes Herzzentrum Kassel
Kassel, Germany, 34121
Kardiologische Praxis Dr. Siegfried Frickel
Kempen, Germany, 47906
Klinik Kitzinger Land
Kitzingen, Germany, 97318
Praxis Dr. Krater
Krefeld, Germany, 47799
Helios Klinikum Krefeld
Krefeld, Germany, 47805
St.-Vinzenz Hospital
Köln, Germany, 50733
Kardiologische Praxis Dr. Fritsch
Köln, Germany, 50737
Malteser Krankenhaus St. Hildegardis
Köln, Germany, 50931
Klinikum der Universität zu Köln- Herzzentrum
Köln, Germany, 50937
Prof. Franzen Institut
Köln, Germany, 50937
Universitätsklinikum Köln-Herzzentrum
Köln, Germany, 50937
Praxis Dr. Anselm Bäumer
Köln, Germany, 51065
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
Köln, Germany, 51105
Klinikum Dahme-Spreewald GmbH
Königs Wusterhausen, Germany, 15711
Universitätsklinikum Leipzig-Herzzentrum
Leipzig, Germany, 04289
Helios Krankenhaus Leisnig
Leisnig, Germany, 04703
Gemeinschaftspraxis Dr. Hilgedieck/Sava
Lengerich, Germany, 49525
Kardiologische Praxis Dr. Faber
Lindlar, Germany, 51784
Ärztezentrum Holthausen-Biene
Lingen, Germany, 49808
Kardiologische Praxis Ludwigsburg
Ludwigsburg, Germany, 71634
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
Lübeck, Germany, 23538
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55101
Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
Mannheim, Germany, 68161
Gemeinschaftspraxis für Herz & Gefäße
Mannheim, Germany, 68161
Universitätsklinik Mannheim-Kardiologie
Mannheim, Germany, 68167
Gemeinschaftspraxis Dres. Brandt / Jakobs
Mannheim, Germany, 68305
Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
Marburg, Germany, 35043
Praxis Dr. Schnabel
Meissen, Germany, 01662
Gemeinschaftspraxis Dr. Jocham
Memmingen, Germany, 87700
Praxis für Kardiologie Dr. med. Menz
Menden, Germany, 58706
Herz-& Gefäßpraxis
Metzingen, Germany, 72555
Praxis Kutenhausen
Minden, Germany, 32425
Krankenhaus Bethanien
Moers, Germany, 47441
Kardiologische Praxis Dr. Schön
Mühldorf, Germany, 84453
Evangelisches Krankenhaus Mülheim
Mülheim an der Ruhr, Germany, 45468
Kardiologie am Rotkreuzplatz
München, Germany, 80634
Gemeinschaftspraxis Dres. Wauer / Windstetter
München, Germany, 80799
Kardiologische Praxis Dr. Herholz
München, Germany, 80809
Klinikum Augustinum München
München, Germany, 81375
Praxis Dres. Böhme/Linke
München, Germany, 81667
Kardiologische Praxis Dr. Muradi
Münster, Germany, 29633
Universitätsklinikum Münster
Münster, Germany, 48149
Praxis für Kardiologie Dr. med. Hewing
Münster, Germany, 48151
Städtisches Khs Lukas
Neuss, Germany, 41472
Kardiologische Praxis Nienburg
Nienburg, Germany, 31582
Klinikum Nürnberg Süd
Nürnberg, Germany, 90471
Kardiologische Praxis Dr. Gumbrecht
Ochtrup, Germany, 48607
Kardiologische Praxis Dr. Hassler
Plauen, Germany, 8523
Kardiologische Praxis Dr. Wiethölter
Radebeul, Germany, 01445
Praxis für Kardiologie Ratingen
Ratingen, Germany, 40878
Praxis Dr. Fröhlich
Ratingen, Germany, 40885
DRK Krankenhaus Mölln-Ratzeburg
Ratzeburg, Germany, 23909
Ambulantes Cardiovaskuläres Centrum
Ravensburg, Germany, 88212
Gemeinschaftspraxis Dr. Weber/Dr. Feja
Recklinghausen, Germany, 45657
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Khs St. Adolf Stift
Reinbek, Germany, 21465
Praxis Dr. Hein
Reinbek, Germany, 21465
Kardiologische Praxis Dr. Kleinz
Remscheid, Germany, 42853
Praxis Dr. Nebel
Rheine, Germany, 48429
Praxis Dr. Kestermann
Rheine, Germany, 48431
Kardiologische Praxis Dr. Figura
Rinteln, Germany, 31737
Kardiologische Praxis Dr. Heinze
Schwerte, Germany, 58239
Praxis Dr. Ebeling
Schönefeld, Germany, 12529
Praxisgemeinschaft Cardio-Soest
Soest, Germany, 59494
Facharztzentrum Sonneberg
Sonneberg, Germany, 96515
Kreiskrankenhaus Stollberg GmbH
Stollberg, Germany, 09366
Kardiologische Praxis Dr. Birkenhagen
Stollberg, Germany, 9366
Klinikum Uelzen GmbH
Uelzen, Germany, 29525
Herzklinik Ulm Dr. Haerer und Partner
Ulm, Germany, 89077
Zentrum für Innere Medizin Uni Ulm
Ulm, Germany, 89081
Katharinen Hospital Unna
Unna, Germany, 59423
Kardiologische Praxis Dr. Burkhard-Meier
Viersen, Germany, 41747
Praxis Dr. Gerritsen
Waldkraiburg, Germany, 84478
Fachkliniken Wangen
Wangen, Germany, 88239
Stiftungsklinik Weißenhorn
Weißenhorn, Germany, 89264
Kardiologisch angiologische Gemeinschaftspraxis
Wiesbaden, Germany, 65183
Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck
Wiesbaden, Germany, 65183
Kardiologische Praxis Dr. Vrettos
Witten, Germany, 58452
Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
Worms, Germany, 67547
Comprehensive Heart Failure Center, Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Evangel. Khs Zweibrücken
Zweibrücken, Germany, 66482
Sponsors and Collaborators
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Principal Investigator: Erland Erdmann, Prof Klinikum der Universität zu Köln
Principal Investigator: Helmut Teschler, Prof Ruhrlandklinik Essen
Study Director: Holger Woehrle, MD ResMed

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ResMed Identifier: NCT01500759    
Other Study ID Numbers: 001
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by ResMed:
chronic heart failure
heart failure
sleep-disordered breathing
cheyne stokes
central sleep apnoea
sleep apnoea
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases