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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01500759
First received: December 23, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Congestive Heart Failure
Left Ventricular Systolic Dysfunction

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ResMed:

Estimated Enrollment: 12000
Study Start Date: November 2007
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500759

  Hide Study Locations
Locations
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne Sleep Disorders Centre
East Melbourne, Victoria, Australia, 3002
St Vincents and Mercy Private Hospital
Melbourne, Victoria, Australia, 3065
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Hollywood Private Hospital (CVS)
Nedlands, Western Australia, Australia, 6009
Germany
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
HDZ NRW
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
Berlin, Germany, 10117
Jüdisches Krankenhaus Berlin
Berlin, Germany, 13347
POLIKUM Friedenau
Berlin, Germany, 12157
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Gemeinschaftspraxis Groß-Ziethener Chaussee
Berlin, Germany, 12355
Praxis Gemeinschaft Frille
Berlin, Germany, 10178
Praxis Westend
Berlin, Germany, 14050
Charité Campus Mitte CCM
Berlin, Germany, 10117
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Herzzentrum Brandenburg
Bernau, Germany, 16321
Praxis für Lunge,Herz und Schlaf
Bielefeld, Germany, 33617
Augusta Krankenanstalten Bochum
Bochum, Germany, 44791
Kardiologische Praxis Dr. Staubach
Bochum, Germany, 44866
Kardiologie Gemeinschaftspraxis Dr. Tenholt
Bochum, Germany, 44787
Kardiologie Kemnade
Bochum, Germany, 44797
Universitätsklinikum Bergmannsheil
Bochum, Germany, 44789
St.-Josephs-Hospital
Bochum, Germany, 44791
Kardiologische Praxis Marschner
Bonn, Germany, 53225
Praxis für Kardiologie Bonn
Bonn, Germany, 53127
Universitätsklinikum Bonn
Bonn, Germany, 53127
Gemeinschaftspraxis Dres. Tinnefeld
Bottrop, Germany, 46240
Gemeinschaftspraxis Kardiologie
Bottrop, Germany, 46236
Kardiologie Bühl
Brühl, Germany, 50321
Mediclin Rehazentrum Spreewald
Burg/Spreewald, Germany, 03096
Kardiologische Praxis Dr. Isbruch
Castrop-Rauxel, Germany, 44577
Gemeinschaftspraxis Kardiologie Dr. Becker
Castrop-Rauxel, Germany, 44575
MVZ am Küchwald
Chemnitz, Germany, 09113
Klinikum Coburg GmbH
Coburg, Germany, 96450
Fachkrankenhaus Coswig
Coswig, Germany, 01640
Carl-Thiem-Klinikum gGmbH
Cottbus, Germany, 03042
Kardiologie - Gemeinschaftspraxis Dortmund
Dortmund, Germany, 44137
Kardiologie-Gemeinschaftspraxis Dortmund
Dortmund, Germany, 44137
Kardiologische Praxis Dr. Golling
Dortmund, Germany, 44137
Kardiologische Praxis Dr. Lodde
Dortmund, Germany, 44147
Kardiologische Praxis Dr. Wetzel
Dortmund, Germany, 44141
Praxis Dr. Hecker
Dortmund, Germany, 44135
Clinical Trial Site Services
Dortmund, Germany, 44141
Kardiologische Praxis Dr. Dröse
Dortmund, Germany, 44263
Klinikum Dortmund gGmbH
Dortmund, Germany, 44137
Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany, 01099
Gemeinschaftpraxis Dres. Schmidt/Gronke
Dresden, Germany, 01219
Herzzentrum Universität Dresden
Dresden, Germany, 01307
Praxis Dr. Hohensee
Dresden, Germany, 01277
Khs Florence-Nightingale
Duesseldorf, Germany, 40489
Florence-Nightingale Krankenhaus
Düsseldorf, Germany, 40489
Gemeinschaftspraxis PD Dr. Lankisch
Düsseldorf, Germany, 40597
Kardiologie Oberkassel
Düsseldorf, Germany, 40545
Kardiologische Praxis Dr. Horowitz
Düsseldorf, Germany, 40215
Kardiologische Praxis Dr. Raff
Düsseldorf, Germany, 40237
goMedus Gesundheitszentrum
Düsseldorf, Germany, 40212
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
Kardiologie Praxis Dr. Bonnekamp
Essen, Germany, 45136
Kardiologische Praxis Dr. Cord Müller
Essen, Germany, 45131
Kardiologische Praxis Prof. Winter
Essen, Germany, 45134
Kath. Kliniken Essen / Philippusstift
Essen, Germany, 45359
Praxis Dr. Rau
Essen, Germany, 45276
Praxis Dr. Tekiyeh
Essen, Germany, 45136
Ruhrlandklinik Essen
Essen, Germany, 45239
Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
Essen, Germany, 45131
Westdeutsches Herzzentrum, Universitätsklinikum Essen
Essen, Germany, 45122
Elisabeth-Krankenhaus Essen
Essen, Germany, 45138
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
Asklepios Klinik Barmbek
Hamburg, Germany, 22291
Gemeinschaftspraxis Dres. Subin/Lutter
Hamburg, Germany, 20095
Kardiologische Praxis Dr. Schröder
Hamburg, Germany, 22765
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Internistenpraxis Alstertal Hamburg
Hamburg, Germany, 22399
Kardiologische Praxis Dr. Cierpka
Hannover, Germany, 30159
Kardiologische Praxis Dr. Hartung
Hannover, Germany, 30559
Praxis Dr. Hötte
Hannover, Germany, 30449
Siloah Krankenhaus
Hannover, Germany, 30449
Heidelberger Praxisklinik für Kardiologie
Heidelberg, Germany, 69115
Praxis Dr. Durak
Heidelberg, Germany, 69115
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Gemeinschaftspraxis Dr. Bruch
Herne, Germany, 44629
Kardiologische Praxis Dr. Furche
Herne, Germany, 44623
Kardiologische Praxis Dr. Schlichting
Herne, Germany, 44649
Evangelisches Krankenhaus Herne
Herne, Germany, 44623
EvK Herne
Herne, Germany, 44623
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
Helios Klinikum Krefeld
Krefeld, Germany, 47805
Praxis Dr. Krater
Krefeld, Germany, 47799
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
Köln, Germany, 51105
Klinikum der Universität zu Köln- Herzzentrum
Köln, Germany, 50937
Malteser Krankenhaus St. Hildegardis
Köln, Germany, 50931
Praxis Dr. Anselm Bäumer
Köln, Germany, 51065
St.-Vinzenz Hospital
Köln, Germany, 50733
Universitätsklinikum Köln-Herzzentrum
Köln, Germany, 50937
Kardiologische Praxis Dr. Fritsch
Köln, Germany, 50737
Prof. Franzen Institut
Köln, Germany, 50937
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. Brandt / Jakobs
Mannheim, Germany, 68305
Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
Mannheim, Germany, 68161
Gemeinschaftspraxis für Herz & Gefäße
Mannheim, Germany, 68161
Universitätsklinik Mannheim-Kardiologie
Mannheim, Germany, 68167
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
Klinikum Augustinum München
München, Germany, 81375
Praxis Dres. Böhme/Linke
München, Germany, 81667
Gemeinschaftspraxis Dres. Wauer / Windstetter
München, Germany, 80799
Kardiologische Praxis Dr. Herholz
München, Germany, 80809
Praxis für Kardiologie Dr. med. Hewing
Münster, Germany, 48151
Universitätsklinikum Münster
Münster, Germany, 48149
Kardiologische Praxis Dr. Muradi
Münster, Germany, 29633
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 Dr. Fröhlich
Ratingen, Germany, 40885
Praxis für Kardiologie Ratingen
Ratingen, Germany, 40878
DRK Krankenhaus Mölln-Ratzeburg
Ratzeburg, Germany, 23909
Ambulantes Cardiovaskuläres Centrum
Ravensburg, Germany, 88212
Gemeinschaftspraxis Dr. Weber/Dr. Feja
Recklinghausen, Germany, 45657
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. Kestermann
Rheine, Germany, 48431
Praxis Dr. Nebel
Rheine, Germany, 48429
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
ResMed
Investigators
Principal Investigator: Erland Erdmann, Prof Klinikum der Universität zu Köln
Principal Investigator: Helmut Teschler, Prof Ruhrlandklinik Essen
Study Director: Holger Woehrle, MD ResMed
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01500759     History of Changes
Other Study ID Numbers: 001
Study First Received: December 23, 2011
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission
Australia: Human Research Ethics Committee

Keywords provided by ResMed:
chronic heart failure
heart failure
hf
sleep-disordered breathing
sdb
nyha
lvef
cheyne stokes
central sleep apnoea
sleep apnoea

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Heart Failure, Systolic
Ventricular Dysfunction, Left
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Ventricular Dysfunction

ClinicalTrials.gov processed this record on July 20, 2014