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

NCT ID: NCT01500759

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6876 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Congestive Heart Failure; Left Ventricular Systolic Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erland Erdmann, Prof

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität zu Köln

Helmut Teschler, Prof

Role: PRINCIPAL_INVESTIGATOR

Ruhrlandklinik Essen

Holger Woehrle, MD

Role: STUDY_DIRECTOR

ResMed

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Rivercity Private Hospital

Auchenflower, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, Australia

St Vincents and Mercy Private Hospital

Melbourne, Victoria, Australia

Melbourne Sleep Disorders Centre

East Melbourne, Victoria 3002, Australia

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, Australia

Cardiopraxis Ingelheim

Ingelheim, Rhineland-Palatinate, Germany

Praxis Dr. Frieske

Aachen, , Germany

Universitätsklinikum Aachen

Aachen, , Germany

DRK Krankenhaus

Alzey, , Germany

Gemeinschaftspraxis Weiß/ Dr. Heesing

Arnsberg, , Germany

Zentralklinikum Bad Berka

Bad Berka, , Germany

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Klinik Lazariterhof

Bad Krozingen, , Germany

Praxis Dr. Bauer

Bad Mergentheim, , Germany

HDZ NRW

Bad Oeynhausen, , Germany

Kardiologische Praxis Dr. Stroh

Bad Wurzach, , Germany

Oberlausitz-Kliniken gGmbH

Bautzen, , Germany

Kardiopraxis Rheinberg

Bergisch Gladbach, , Germany

Charité Campus Mitte CCM

Berlin, , Germany

Charité Campus Mitte

Berlin, , Germany

Praxis Gemeinschaft Frille

Berlin, , Germany

POLIKUM Friedenau

Berlin, , Germany

Gemeinschaftspraxis Groß-Ziethener Chaussee

Berlin, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Charité Campus Virchow Klinikum

Berlin, , Germany

Charité Campus Virchow-Klinikum

Berlin, , Germany

Praxis Westend

Berlin, , Germany

Herzzentrum Brandenburg

Bernau, , Germany

Praxis für Lunge,Herz und Schlaf

Bielefeld, , Germany

Kardiologie Gemeinschaftspraxis Dr. Tenholt

Bochum, , Germany

Universitätsklinikum Bergmannsheil

Bochum, , Germany

Augusta Krankenanstalten Bochum

Bochum, , Germany

St.-Josephs-Hospital

Bochum, , Germany

Kardiologie Kemnade

Bochum, , Germany

Kardiologische Praxis Dr. Staubach

Bochum, , Germany

Praxis für Kardiologie Bonn

Bonn, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Kardiologische Praxis Marschner

Bonn, , Germany

Gemeinschaftspraxis Kardiologie

Bottrop, , Germany

Gemeinschaftspraxis Dres. Tinnefeld

Bottrop, , Germany

Kardiologie Bühl

Brühl, , Germany

Mediclin Rehazentrum Spreewald

Burg, , Germany

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, , Germany

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, , Germany

MVZ am Küchwald

Chemnitz, , Germany

Klinikum Coburg GmbH

Coburg, , Germany

St.-Vinzenz Hospital

Cologne, , Germany

Kardiologische Praxis Dr. Fritsch

Cologne, , Germany

Malteser Krankenhaus St. Hildegardis

Cologne, , Germany

Klinikum der Universität zu Köln- Herzzentrum

Cologne, , Germany

Prof. Franzen Institut

Cologne, , Germany

Universitätsklinikum Köln-Herzzentrum

Cologne, , Germany

Praxis Dr. Anselm Bäumer

Cologne, , Germany

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, , Germany

Fachkrankenhaus Coswig

Coswig, , Germany

Carl-Thiem-Klinikum gGmbH

Cottbus, , Germany

Praxis Dr. Hecker

Dortmund, , Germany

Kardiologie - Gemeinschaftspraxis Dortmund

Dortmund, , Germany

Kardiologie-Gemeinschaftspraxis Dortmund

Dortmund, , Germany

Kardiologische Praxis Dr. Golling

Dortmund, , Germany

Klinikum Dortmund gGmbH

Dortmund, , Germany

Clinical Trial Site Services

Dortmund, , Germany

Kardiologische Praxis Dr. Wetzel

Dortmund, , Germany

Kardiologische Praxis Dr. Lodde

Dortmund, , Germany

Kardiologische Praxis Dr. Dröse

Dortmund, , Germany

Facharztzentrum Dresden-Neustadt GbR

Dresden, , Germany

Gemeinschaftpraxis Dres. Schmidt/Gronke

Dresden, , Germany

Praxis Dr. Hohensee

Dresden, , Germany

Herzzentrum Universität Dresden

Dresden, , Germany

goMedus Gesundheitszentrum

Düsseldorf, , Germany

Kardiologische Praxis Dr. Horowitz

Düsseldorf, , Germany

Kardiologische Praxis Dr. Raff

Düsseldorf, , Germany

Florence-Nightingale Krankenhaus

Düsseldorf, , Germany

Khs Florence-Nightingale

Düsseldorf, , Germany

Kardiologie Oberkassel

Düsseldorf, , Germany

Gemeinschaftspraxis PD Dr. Lankisch

Düsseldorf, , Germany

Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl

Emmendingen, , Germany

Helios Klinikum Erfurt-Kardiologie

Erfurt, , Germany

Helios Klinikum Erfurt-Schlafmedizin

Erfurt, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Westdeutsches Herzzentrum, Universitätsklinikum Essen

Essen, , Germany

Kardiologische Praxis Dr. Cord Müller

Essen, , Germany

Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

Essen, , Germany

Kardiologische Praxis Prof. Winter

Essen, , Germany

Kardiologie Praxis Dr. Bonnekamp

Essen, , Germany

Praxis Dr. Tekiyeh

Essen, , Germany

Elisabeth-Krankenhaus Essen

Essen, , Germany

Ruhrlandklinik Essen

Essen, , Germany

Praxis Dr. Rau

Essen, , Germany

Kath. Kliniken Essen / Philippusstift

Essen, , Germany

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, , Germany

Kardiologische Praxis Dr. Kruse

Forst, , Germany

CardioVasculäres Centrum Frankfurt

Frankfurt, , Germany

Praxis Dr. Diedrichs

Frechen, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Gemeinschaftspraxis Dres. Böhmeke/Schmidt

Gladbeck, , Germany

Kardiologische Praxis Dr. Hug

Günzburg, , Germany

Kardiologische Praxis Gütersloh

Gütersloh, , Germany

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, , Germany

Kardiologische Praxis Dr. Arens

Hagen, , Germany

Gemeinschaftspraxis Dres. Subin/Lutter

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Internistenpraxis Alstertal Hamburg

Hamburg, , Germany

Kardiologische Praxis Dr. Schröder

Hamburg, , Germany

Kardiologische Praxis Dr. Cierpka

Hanover, , Germany

Praxis Dr. Hötte

Hanover, , Germany

Siloah Krankenhaus

Hanover, , Germany

Kardiologische Praxis Dr. Hartung

Hanover, , Germany

Heidelberger Praxisklinik für Kardiologie

Heidelberg, , Germany

Praxis Dr. Durak

Heidelberg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, , Germany

Evangelisches Krankenhaus Herne

Herne, , Germany

EvK Herne

Herne, , Germany

Kardiologische Praxis Dr. Furche

Herne, , Germany

Gemeinschaftspraxis Dr. Bruch

Herne, , Germany

Kardiologische Praxis Dr. Schlichting

Herne, , Germany

St. Elisabeth-Hospital Herten gGmbH

Herten, , Germany

Praxis für Innere Medizin/Kardiologie

Hoyerswerda, , Germany

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, , Germany

Ambulantes Herzzentrum Kassel

Kassel, , Germany

Kardiologische Praxis Dr. Siegfried Frickel

Kempen, , Germany

Klinik Kitzinger Land

Kitzingen, , Germany

Klinikum Dahme-Spreewald GmbH

Königs Wusterhausen, , Germany

Praxis Dr. Krater

Krefeld, , Germany

Helios Klinikum Krefeld

Krefeld, , Germany

Universitätsklinikum Leipzig-Herzzentrum

Leipzig, , Germany

Helios Krankenhaus Leisnig

Leisnig, , Germany

Gemeinschaftspraxis Dr. Hilgedieck/Sava

Lengerich, , Germany

Kardiologische Praxis Dr. Faber

Lindlar, , Germany

Ärztezentrum Holthausen-Biene

Lingen, , Germany

Kardiologische Praxis Ludwigsburg

Ludwigsburg, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, , Germany

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

Mannheim, , Germany

Gemeinschaftspraxis für Herz & Gefäße

Mannheim, , Germany

Universitätsklinik Mannheim-Kardiologie

Mannheim, , Germany

Gemeinschaftspraxis Dres. Brandt / Jakobs

Mannheim, , Germany

Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

Marburg, , Germany

Praxis Dr. Schnabel

Meissen, , Germany

Gemeinschaftspraxis Dr. Jocham

Memmingen, , Germany

Praxis für Kardiologie Dr. med. Menz

Menden, , Germany

Herz-& Gefäßpraxis

Metzingen, , Germany

Praxis Kutenhausen

Minden, , Germany

Krankenhaus Bethanien

Moers, , Germany

Kardiologische Praxis Dr. Schön

Mühldorf, , Germany

Evangelisches Krankenhaus Mülheim

Mülheim, , Germany

Kardiologie am Rotkreuzplatz

München, , Germany

Gemeinschaftspraxis Dres. Wauer / Windstetter

München, , Germany

Kardiologische Praxis Dr. Herholz

München, , Germany

Klinikum Augustinum München

München, , Germany

Praxis Dres. Böhme/Linke

München, , Germany

Kardiologische Praxis Dr. Muradi

Münster, , Germany

Universitätsklinikum Münster

Münster, , Germany

Praxis für Kardiologie Dr. med. Hewing

Münster, , Germany

Städtisches Khs Lukas

Neuss, , Germany

Kardiologische Praxis Nienburg

Nienburg, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Kardiologische Praxis Dr. Gumbrecht

Ochtrup, , Germany

Kardiologische Praxis Dr. Hassler

Plauen, , Germany

Kardiologische Praxis Dr. Wiethölter

Radebeul, , Germany

Praxis für Kardiologie Ratingen

Ratingen, , Germany

Praxis Dr. Fröhlich

Ratingen, , Germany

DRK Krankenhaus Mölln-Ratzeburg

Ratzeburg, , Germany

Ambulantes Cardiovaskuläres Centrum

Ravensburg, , Germany

Gemeinschaftspraxis Dr. Weber/Dr. Feja

Recklinghausen, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Khs St. Adolf Stift

Reinbek, , Germany

Praxis Dr. Hein

Reinbek, , Germany

Kardiologische Praxis Dr. Kleinz

Remscheid, , Germany

Praxis Dr. Nebel

Rheine, , Germany

Praxis Dr. Kestermann

Rheine, , Germany

Kardiologische Praxis Dr. Figura

Rinteln, , Germany

Praxis Dr. Ebeling

Schönefeld, , Germany

Kardiologische Praxis Dr. Heinze

Schwerte, , Germany

Praxisgemeinschaft Cardio-Soest

Soest, , Germany

Facharztzentrum Sonneberg

Sonneberg, , Germany

Kreiskrankenhaus Stollberg GmbH

Stollberg, , Germany

Kardiologische Praxis Dr. Birkenhagen

Stollberg, , Germany

Klinikum Uelzen GmbH

Uelzen, , Germany

Herzklinik Ulm Dr. Haerer und Partner

Ulm, , Germany

Zentrum für Innere Medizin Uni Ulm

Ulm, , Germany

Katharinen Hospital Unna

Unna, , Germany

Kardiologische Praxis Dr. Burkhard-Meier

Viersen, , Germany

Praxis Dr. Gerritsen

Waldkraiburg, , Germany

Fachkliniken Wangen

Wangen, , Germany

Stiftungsklinik Weißenhorn

Weißenhorn, , Germany

Kardiologisch angiologische Gemeinschaftspraxis

Wiesbaden, , Germany

Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

Wiesbaden, , Germany

Kardiologische Praxis Dr. Vrettos

Witten, , Germany

Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

Worms, , Germany

Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

Würzburg, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Evangel. Khs Zweibrücken

Zweibrücken, , Germany

Countries

Australia; Germany

References

Woehrle H, Oldenburg O, Arzt M, Graml A, Erdmann E, Teschler H, Wegscheider K; SCHLA-HF Investigators. Determining the prevalence and predictors of sleep disordered breathing in patients with chronic heart failure: rationale and design of the SCHLA-HF registry. BMC Cardiovasc Disord. 2014 Apr 9;14:46. doi: 10.1186/1471-2261-14-46.

Reference Type: RESULT

PMID: 24716484 (View on PubMed)

Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A, Erdmann E, Teschler H, Wegscheider K; SchlaHF Investigators. Prevalence and Predictors of Sleep-Disordered Breathing in Patients With Stable Chronic Heart Failure: The SchlaHF Registry. JACC Heart Fail. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9.

Reference Type: RESULT

PMID: 26682790 (View on PubMed)

Arzt M, Oldenburg O, Graml A, Erdmann E, Teschler H, Wegscheider K, Suling A, Woehrle H; SchlaHF Investigators. Phenotyping of Sleep-Disordered Breathing in Patients With Chronic Heart Failure With Reduced Ejection Fraction-the SchlaHF Registry. J Am Heart Assoc. 2017 Nov 29;6(12):e005899. doi: 10.1161/JAHA.116.005899.

Reference Type: RESULT

PMID: 29187390 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id