NCT01500759

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
2 countries

199 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

May 1, 2020

Enrollment Period

5.5 years

First QC Date

December 23, 2011

Results QC Date

May 1, 2020

Last Update Submit

June 25, 2020

Conditions

Keywords

chronic heart failureheart failurehfsleep-disordered breathingsdbnyhalvefcheyne stokescentral sleep apnoeasleep apnoea

Outcome Measures

Primary Outcomes (1)

  • Prevalence of SDB in Chronic HF Patients

    SDB= Sleep disordered breathing; HF= Heart failure

    1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility

Secondary Outcomes (22)

  • Left Ventricular Ejection Fraction

    1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution

  • Age

    1-time single assessment at baseline

  • Body Mass Index

    1-time single assessment at baseline

  • Male Gender

    1-time single assessment at baseline

  • NYHA Class ≥III

    At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records

  • +17 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • Patient is able to fully understand study information and signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (199)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Rivercity Private Hospital

Auchenflower, Queensland, 4066, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

St Vincents and Mercy Private Hospital

Melbourne, Victoria, 3065, Australia

Location

Melbourne Sleep Disorders Centre

East Melbourne, Victoria 3002, 3002, Australia

Location

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, 6009, Australia

Location

Cardiopraxis Ingelheim

Ingelheim, Rhineland-Palatinate, 55218, Germany

Location

Praxis Dr. Frieske

Aachen, 52062, Germany

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

DRK Krankenhaus

Alzey, 55232, Germany

Location

Gemeinschaftspraxis Weiß/ Dr. Heesing

Arnsberg, 59821, Germany

Location

Zentralklinikum Bad Berka

Bad Berka, 99437, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Klinik Lazariterhof

Bad Krozingen, 79189, Germany

Location

Praxis Dr. Bauer

Bad Mergentheim, 97980, Germany

Location

HDZ NRW

Bad Oeynhausen, 32545, Germany

Location

Kardiologische Praxis Dr. Stroh

Bad Wurzach, 88410, Germany

Location

Oberlausitz-Kliniken gGmbH

Bautzen, 02625, Germany

Location

Kardiopraxis Rheinberg

Bergisch Gladbach, 51465, Germany

Location

Charité Campus Mitte CCM

Berlin, 10117, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

Praxis Gemeinschaft Frille

Berlin, 10178, Germany

Location

POLIKUM Friedenau

Berlin, 12157, Germany

Location

Gemeinschaftspraxis Groß-Ziethener Chaussee

Berlin, 12355, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

Location

Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Praxis Westend

Berlin, 14050, Germany

Location

Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Praxis für Lunge,Herz und Schlaf

Bielefeld, 33617, Germany

Location

Kardiologie Gemeinschaftspraxis Dr. Tenholt

Bochum, 44787, Germany

Location

Universitätsklinikum Bergmannsheil

Bochum, 44789, Germany

Location

Augusta Krankenanstalten Bochum

Bochum, 44791, Germany

Location

St.-Josephs-Hospital

Bochum, 44791, Germany

Location

Kardiologie Kemnade

Bochum, 44797, Germany

Location

Kardiologische Praxis Dr. Staubach

Bochum, 44866, Germany

Location

Praxis für Kardiologie Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Kardiologische Praxis Marschner

Bonn, 53225, Germany

Location

Gemeinschaftspraxis Kardiologie

Bottrop, 46236, Germany

Location

Gemeinschaftspraxis Dres. Tinnefeld

Bottrop, 46240, Germany

Location

Kardiologie Bühl

Brühl, 50321, Germany

Location

Mediclin Rehazentrum Spreewald

Burg, 03096, Germany

Location

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, 44575, Germany

Location

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, 44577, Germany

Location

MVZ am Küchwald

Chemnitz, 09113, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

St.-Vinzenz Hospital

Cologne, 50733, Germany

Location

Kardiologische Praxis Dr. Fritsch

Cologne, 50737, Germany

Location

Malteser Krankenhaus St. Hildegardis

Cologne, 50931, Germany

Location

Klinikum der Universität zu Köln- Herzzentrum

Cologne, 50937, Germany

Location

Prof. Franzen Institut

Cologne, 50937, Germany

Location

Universitätsklinikum Köln-Herzzentrum

Cologne, 50937, Germany

Location

Praxis Dr. Anselm Bäumer

Cologne, 51065, Germany

Location

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, 51105, Germany

Location

Fachkrankenhaus Coswig

Coswig, 01640, Germany

Location

Carl-Thiem-Klinikum gGmbH

Cottbus, 03042, Germany

Location

Praxis Dr. Hecker

Dortmund, 44135, Germany

Location

Kardiologie - Gemeinschaftspraxis Dortmund

Dortmund, 44137, Germany

Location

Kardiologie-Gemeinschaftspraxis Dortmund

Dortmund, 44137, Germany

Location

Kardiologische Praxis Dr. Golling

Dortmund, 44137, Germany

Location

Klinikum Dortmund gGmbH

Dortmund, 44137, Germany

Location

Clinical Trial Site Services

Dortmund, 44141, Germany

Location

Kardiologische Praxis Dr. Wetzel

Dortmund, 44141, Germany

Location

Kardiologische Praxis Dr. Lodde

Dortmund, 44147, Germany

Location

Kardiologische Praxis Dr. Dröse

Dortmund, 44263, Germany

Location

Facharztzentrum Dresden-Neustadt GbR

Dresden, 01099, Germany

Location

Gemeinschaftpraxis Dres. Schmidt/Gronke

Dresden, 01219, Germany

Location

Praxis Dr. Hohensee

Dresden, 01277, Germany

Location

Herzzentrum Universität Dresden

Dresden, 01307, Germany

Location

goMedus Gesundheitszentrum

Düsseldorf, 40212, Germany

Location

Kardiologische Praxis Dr. Horowitz

Düsseldorf, 40215, Germany

Location

Kardiologische Praxis Dr. Raff

Düsseldorf, 40237, Germany

Location

Florence-Nightingale Krankenhaus

Düsseldorf, 40489, Germany

Location

Khs Florence-Nightingale

Düsseldorf, 40489, Germany

Location

Kardiologie Oberkassel

Düsseldorf, 40545, Germany

Location

Gemeinschaftspraxis PD Dr. Lankisch

Düsseldorf, 40597, Germany

Location

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

Emmendingen, 79312, Germany

Location

Helios Klinikum Erfurt-Kardiologie

Erfurt, 99089, Germany

Location

Helios Klinikum Erfurt-Schlafmedizin

Erfurt, 99089, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Westdeutsches Herzzentrum, Universitätsklinikum Essen

Essen, 45122, Germany

Location

Kardiologische Praxis Dr. Cord Müller

Essen, 45131, Germany

Location

Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

Essen, 45131, Germany

Location

Kardiologische Praxis Prof. Winter

Essen, 45134, Germany

Location

Kardiologie Praxis Dr. Bonnekamp

Essen, 45136, Germany

Location

Praxis Dr. Tekiyeh

Essen, 45136, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, 45138, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Praxis Dr. Rau

Essen, 45276, Germany

Location

Kath. Kliniken Essen / Philippusstift

Essen, 45359, Germany

Location

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, 55237, Germany

Location

Kardiologische Praxis Dr. Kruse

Forst, 03149, Germany

Location

CardioVasculäres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Praxis Dr. Diedrichs

Frechen, 50226, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Gemeinschaftspraxis Dres. Böhmeke/Schmidt

Gladbeck, 45964, Germany

Location

Kardiologische Praxis Dr. Hug

Günzburg, 89312, Germany

Location

Kardiologische Praxis Gütersloh

Gütersloh, 33330, Germany

Location

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, 58095, Germany

Location

Kardiologische Praxis Dr. Arens

Hagen, 58095, Germany

Location

Gemeinschaftspraxis Dres. Subin/Lutter

Hamburg, 20095, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

Location

Internistenpraxis Alstertal Hamburg

Hamburg, 22399, Germany

Location

Kardiologische Praxis Dr. Schröder

Hamburg, 22765, Germany

Location

Kardiologische Praxis Dr. Cierpka

Hanover, 30159, Germany

Location

Praxis Dr. Hötte

Hanover, 30449, Germany

Location

Siloah Krankenhaus

Hanover, 30449, Germany

Location

Kardiologische Praxis Dr. Hartung

Hanover, 30559, Germany

Location

Heidelberger Praxisklinik für Kardiologie

Heidelberg, 69115, Germany

Location

Praxis Dr. Durak

Heidelberg, 69115, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Evangelisches Krankenhaus Herne

Herne, 44623, Germany

Location

EvK Herne

Herne, 44623, Germany

Location

Kardiologische Praxis Dr. Furche

Herne, 44623, Germany

Location

Gemeinschaftspraxis Dr. Bruch

Herne, 44629, Germany

Location

Kardiologische Praxis Dr. Schlichting

Herne, 44649, Germany

Location

St. Elisabeth-Hospital Herten gGmbH

Herten, 45699, Germany

Location

Praxis für Innere Medizin/Kardiologie

Hoyerswerda, 02977, Germany

Location

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, 97753, Germany

Location

Ambulantes Herzzentrum Kassel

Kassel, 34121, Germany

Location

Kardiologische Praxis Dr. Siegfried Frickel

Kempen, 47906, Germany

Location

Klinik Kitzinger Land

Kitzingen, 97318, Germany

Location

Klinikum Dahme-Spreewald GmbH

Königs Wusterhausen, 15711, Germany

Location

Praxis Dr. Krater

Krefeld, 47799, Germany

Location

Helios Klinikum Krefeld

Krefeld, 47805, Germany

Location

Universitätsklinikum Leipzig-Herzzentrum

Leipzig, 04289, Germany

Location

Helios Krankenhaus Leisnig

Leisnig, 04703, Germany

Location

Gemeinschaftspraxis Dr. Hilgedieck/Sava

Lengerich, 49525, Germany

Location

Kardiologische Praxis Dr. Faber

Lindlar, 51784, Germany

Location

Ärztezentrum Holthausen-Biene

Lingen, 49808, Germany

Location

Kardiologische Praxis Ludwigsburg

Ludwigsburg, 71634, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, 23538, Germany

Location

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

Location

Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

Mannheim, 68161, Germany

Location

Gemeinschaftspraxis für Herz & Gefäße

Mannheim, 68161, Germany

Location

Universitätsklinik Mannheim-Kardiologie

Mannheim, 68167, Germany

Location

Gemeinschaftspraxis Dres. Brandt / Jakobs

Mannheim, 68305, Germany

Location

Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

Marburg, 35043, Germany

Location

Praxis Dr. Schnabel

Meissen, 01662, Germany

Location

Gemeinschaftspraxis Dr. Jocham

Memmingen, 87700, Germany

Location

Praxis für Kardiologie Dr. med. Menz

Menden, 58706, Germany

Location

Herz-& Gefäßpraxis

Metzingen, 72555, Germany

Location

Praxis Kutenhausen

Minden, 32425, Germany

Location

Krankenhaus Bethanien

Moers, 47441, Germany

Location

Kardiologische Praxis Dr. Schön

Mühldorf, 84453, Germany

Location

Evangelisches Krankenhaus Mülheim

Mülheim, 45468, Germany

Location

Kardiologie am Rotkreuzplatz

München, 80634, Germany

Location

Gemeinschaftspraxis Dres. Wauer / Windstetter

München, 80799, Germany

Location

Kardiologische Praxis Dr. Herholz

München, 80809, Germany

Location

Klinikum Augustinum München

München, 81375, Germany

Location

Praxis Dres. Böhme/Linke

München, 81667, Germany

Location

Kardiologische Praxis Dr. Muradi

Münster, 29633, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Praxis für Kardiologie Dr. med. Hewing

Münster, 48151, Germany

Location

Städtisches Khs Lukas

Neuss, 41472, Germany

Location

Kardiologische Praxis Nienburg

Nienburg, 31582, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Kardiologische Praxis Dr. Gumbrecht

Ochtrup, 48607, Germany

Location

Kardiologische Praxis Dr. Hassler

Plauen, 8523, Germany

Location

Kardiologische Praxis Dr. Wiethölter

Radebeul, 01445, Germany

Location

Praxis für Kardiologie Ratingen

Ratingen, 40878, Germany

Location

Praxis Dr. Fröhlich

Ratingen, 40885, Germany

Location

DRK Krankenhaus Mölln-Ratzeburg

Ratzeburg, 23909, Germany

Location

Ambulantes Cardiovaskuläres Centrum

Ravensburg, 88212, Germany

Location

Gemeinschaftspraxis Dr. Weber/Dr. Feja

Recklinghausen, 45657, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Khs St. Adolf Stift

Reinbek, 21465, Germany

Location

Praxis Dr. Hein

Reinbek, 21465, Germany

Location

Kardiologische Praxis Dr. Kleinz

Remscheid, 42853, Germany

Location

Praxis Dr. Nebel

Rheine, 48429, Germany

Location

Praxis Dr. Kestermann

Rheine, 48431, Germany

Location

Kardiologische Praxis Dr. Figura

Rinteln, 31737, Germany

Location

Praxis Dr. Ebeling

Schönefeld, 12529, Germany

Location

Kardiologische Praxis Dr. Heinze

Schwerte, 58239, Germany

Location

Praxisgemeinschaft Cardio-Soest

Soest, 59494, Germany

Location

Facharztzentrum Sonneberg

Sonneberg, 96515, Germany

Location

Kreiskrankenhaus Stollberg GmbH

Stollberg, 09366, Germany

Location

Kardiologische Praxis Dr. Birkenhagen

Stollberg, 9366, Germany

Location

Klinikum Uelzen GmbH

Uelzen, 29525, Germany

Location

Herzklinik Ulm Dr. Haerer und Partner

Ulm, 89077, Germany

Location

Zentrum für Innere Medizin Uni Ulm

Ulm, 89081, Germany

Location

Katharinen Hospital Unna

Unna, 59423, Germany

Location

Kardiologische Praxis Dr. Burkhard-Meier

Viersen, 41747, Germany

Location

Praxis Dr. Gerritsen

Waldkraiburg, 84478, Germany

Location

Fachkliniken Wangen

Wangen, 88239, Germany

Location

Stiftungsklinik Weißenhorn

Weißenhorn, 89264, Germany

Location

Kardiologisch angiologische Gemeinschaftspraxis

Wiesbaden, 65183, Germany

Location

Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

Wiesbaden, 65183, Germany

Location

Kardiologische Praxis Dr. Vrettos

Witten, 58452, Germany

Location

Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

Worms, 67547, Germany

Location

Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Evangel. Khs Zweibrücken

Zweibrücken, 66482, Germany

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart FailureVentricular Dysfunction, LeftSleep Apnea SyndromesCheyne-Stokes RespirationSleep Apnea, Central

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular DysfunctionApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Affairs CRS
Organization
ResMed Germany Inc

Study Officials

  • Erland Erdmann, Prof

    Klinikum der Universität zu Köln

    PRINCIPAL INVESTIGATOR
  • Helmut Teschler, Prof

    Ruhrlandklinik Essen

    PRINCIPAL INVESTIGATOR
  • Holger Woehrle, MD

    ResMed

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2011

First Posted

December 28, 2011

Study Start

November 1, 2007

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 9, 2020

Results First Posted

July 9, 2020

Record last verified: 2020-05

Locations