AzTrials
AzTrials

Congestive Heart FailureSchlaHFNCT01500759

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

An observational study of Congestive Heart Failure and Left Ventricular Systolic Dysfunction, run by ResMed at 199 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
6,876 participants
Where
199 sitesin 2 countries
Study dates
Nov 2007to May 2013
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

199 sites in 2 countries.

199 sites in 2 countries

Germany192 sites

  • Praxis Dr. Frieske

    Aachen, 52062

  • Universitätsklinikum Aachen

    Aachen, 52074

  • DRK Krankenhaus

    Alzey, 55232

  • Gemeinschaftspraxis Weiß/ Dr. Heesing

    Arnsberg, 59821

  • Zentralklinikum Bad Berka

    Bad Berka, 99437

  • Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Klinik Lazariterhof

    Bad Krozingen, 79189

  • Praxis Dr. Bauer

    Bad Mergentheim, 97980

  • HDZ NRW

    Bad Oeynhausen, 32545

  • Kardiologische Praxis Dr. Stroh

    Bad Wurzach, 88410

  • Oberlausitz-Kliniken gGmbH

    Bautzen, 02625

  • Kardiopraxis Rheinberg

    Bergisch Gladbach, 51465

  • Charité Campus Mitte CCM

    Berlin, 10117

  • Charité Campus Mitte

    Berlin, 10117

  • Praxis Gemeinschaft Frille

    Berlin, 10178

  • POLIKUM Friedenau

    Berlin, 12157

  • Gemeinschaftspraxis Groß-Ziethener Chaussee

    Berlin, 12355

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • Charité Campus Virchow-Klinikum

    Berlin, 13353

  • Praxis Westend

    Berlin, 14050

  • Herzzentrum Brandenburg

    Bernau, 16321

  • Praxis für Lunge,Herz und Schlaf

    Bielefeld, 33617

  • Kardiologie Gemeinschaftspraxis Dr. Tenholt

    Bochum, 44787

  • Universitätsklinikum Bergmannsheil

    Bochum, 44789

  • Augusta Krankenanstalten Bochum

    Bochum, 44791

  • St.-Josephs-Hospital

    Bochum, 44791

  • Kardiologie Kemnade

    Bochum, 44797

  • Kardiologische Praxis Dr. Staubach

    Bochum, 44866

  • Praxis für Kardiologie Bonn

    Bonn, 53127

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Kardiologische Praxis Marschner

    Bonn, 53225

  • Gemeinschaftspraxis Kardiologie

    Bottrop, 46236

  • Gemeinschaftspraxis Dres. Tinnefeld

    Bottrop, 46240

  • Kardiologie Bühl

    Brühl, 50321

  • Mediclin Rehazentrum Spreewald

    Burg, 03096

  • Gemeinschaftspraxis Kardiologie Dr. Becker

    Castrop-Rauxel, 44575

  • Kardiologische Praxis Dr. Isbruch

    Castrop-Rauxel, 44577

  • MVZ am Küchwald

    Chemnitz, 09113

  • Klinikum Coburg GmbH

    Coburg, 96450

  • St.-Vinzenz Hospital

    Cologne, 50733

  • Kardiologische Praxis Dr. Fritsch

    Cologne, 50737

  • Malteser Krankenhaus St. Hildegardis

    Cologne, 50931

  • Klinikum der Universität zu Köln- Herzzentrum

    Cologne, 50937

  • Prof. Franzen Institut

    Cologne, 50937

  • Universitätsklinikum Köln-Herzzentrum

    Cologne, 50937

  • Praxis Dr. Anselm Bäumer

    Cologne, 51065

  • Gemeinschaftspraxis Dres. Gysan/Heinzler/May

    Cologne, 51105

  • Fachkrankenhaus Coswig

    Coswig, 01640

  • Carl-Thiem-Klinikum gGmbH

    Cottbus, 03042

  • Praxis Dr. Hecker

    Dortmund, 44135

  • Kardiologie - Gemeinschaftspraxis Dortmund

    Dortmund, 44137

  • Kardiologie-Gemeinschaftspraxis Dortmund

    Dortmund, 44137

  • Kardiologische Praxis Dr. Golling

    Dortmund, 44137

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • Clinical Trial Site Services

    Dortmund, 44141

  • Kardiologische Praxis Dr. Wetzel

    Dortmund, 44141

  • Kardiologische Praxis Dr. Lodde

    Dortmund, 44147

  • Kardiologische Praxis Dr. Dröse

    Dortmund, 44263

  • Facharztzentrum Dresden-Neustadt GbR

    Dresden, 01099

  • Gemeinschaftpraxis Dres. Schmidt/Gronke

    Dresden, 01219

  • Praxis Dr. Hohensee

    Dresden, 01277

  • Herzzentrum Universität Dresden

    Dresden, 01307

  • goMedus Gesundheitszentrum

    Düsseldorf, 40212

  • Kardiologische Praxis Dr. Horowitz

    Düsseldorf, 40215

  • Kardiologische Praxis Dr. Raff

    Düsseldorf, 40237

  • Florence-Nightingale Krankenhaus

    Düsseldorf, 40489

  • Khs Florence-Nightingale

    Düsseldorf, 40489

  • Kardiologie Oberkassel

    Düsseldorf, 40545

  • Gemeinschaftspraxis PD Dr. Lankisch

    Düsseldorf, 40597

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

    Emmendingen, 79312

  • Helios Klinikum Erfurt-Kardiologie

    Erfurt, 99089

  • Helios Klinikum Erfurt-Schlafmedizin

    Erfurt, 99089

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Westdeutsches Herzzentrum, Universitätsklinikum Essen

    Essen, 45122

  • Kardiologische Praxis Dr. Cord Müller

    Essen, 45131

  • Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

    Essen, 45131

  • Kardiologische Praxis Prof. Winter

    Essen, 45134

  • Kardiologie Praxis Dr. Bonnekamp

    Essen, 45136

  • Praxis Dr. Tekiyeh

    Essen, 45136

  • Elisabeth-Krankenhaus Essen

    Essen, 45138

  • Ruhrlandklinik Essen

    Essen, 45239

  • Praxis Dr. Rau

    Essen, 45276

  • Kath. Kliniken Essen / Philippusstift

    Essen, 45359

  • Gemeinschaftspraxis Dres. Guckenbiehl

    Flonheim, 55237

  • Kardiologische Praxis Dr. Kruse

    Forst, 03149

  • CardioVasculäres Centrum Frankfurt

    Frankfurt, 60389

  • Praxis Dr. Diedrichs

    Frechen, 50226

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Gemeinschaftspraxis Dres. Böhmeke/Schmidt

    Gladbeck, 45964

  • Kardiologische Praxis Dr. Hug

    Günzburg, 89312

  • Kardiologische Praxis Gütersloh

    Gütersloh, 33330

  • Gemeinschaftspraxis Dres Leischik/Littwitz

    Hagen, 58095

  • Kardiologische Praxis Dr. Arens

    Hagen, 58095

  • Gemeinschaftspraxis Dres. Subin/Lutter

    Hamburg, 20095

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Internistenpraxis Alstertal Hamburg

    Hamburg, 22399

  • Kardiologische Praxis Dr. Schröder

    Hamburg, 22765

  • Kardiologische Praxis Dr. Cierpka

    Hanover, 30159

  • Praxis Dr. Hötte

    Hanover, 30449

  • Siloah Krankenhaus

    Hanover, 30449

  • Kardiologische Praxis Dr. Hartung

    Hanover, 30559

  • Heidelberger Praxisklinik für Kardiologie

    Heidelberg, 69115

  • Praxis Dr. Durak

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Evangelisches Krankenhaus Herne

    Herne, 44623

  • EvK Herne

    Herne, 44623

  • Kardiologische Praxis Dr. Furche

    Herne, 44623

  • Gemeinschaftspraxis Dr. Bruch

    Herne, 44629

  • Kardiologische Praxis Dr. Schlichting

    Herne, 44649

  • St. Elisabeth-Hospital Herten gGmbH

    Herten, 45699

  • Praxis für Innere Medizin/Kardiologie

    Hoyerswerda, 02977

  • Cardiopraxis Ingelheim

    Ingelheim, Rhineland-Palatinate, 55218

  • Gemeinschaftspraxis Dres. Dobler/Turin

    Karlstadt am Main, 97753

  • Ambulantes Herzzentrum Kassel

    Kassel, 34121

  • Kardiologische Praxis Dr. Siegfried Frickel

    Kempen, 47906

  • Klinik Kitzinger Land

    Kitzingen, 97318

  • Klinikum Dahme-Spreewald GmbH

    Königs Wusterhausen, 15711

  • Praxis Dr. Krater

    Krefeld, 47799

  • Helios Klinikum Krefeld

    Krefeld, 47805

  • Universitätsklinikum Leipzig-Herzzentrum

    Leipzig, 04289

  • Helios Krankenhaus Leisnig

    Leisnig, 04703

  • Gemeinschaftspraxis Dr. Hilgedieck/Sava

    Lengerich, 49525

  • Kardiologische Praxis Dr. Faber

    Lindlar, 51784

  • Ärztezentrum Holthausen-Biene

    Lingen, 49808

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

    Lübeck, 23538

  • Kardiologische Praxis Ludwigsburg

    Ludwigsburg, 71634

  • Klinikum der Johannes Gutenberg-Universität Mainz

    Mainz, 55101

  • Gemeinschaftspraxis Dres. Heifer/Loster/Schernus

    Mannheim, 68161

  • Gemeinschaftspraxis für Herz & Gefäße

    Mannheim, 68161

  • Universitätsklinik Mannheim-Kardiologie

    Mannheim, 68167

  • Gemeinschaftspraxis Dres. Brandt / Jakobs

    Mannheim, 68305

  • Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

    Marburg, 35043

  • Praxis Dr. Schnabel

    Meissen, 01662

  • Gemeinschaftspraxis Dr. Jocham

    Memmingen, 87700

  • Praxis für Kardiologie Dr. med. Menz

    Menden, 58706

  • Herz-& Gefäßpraxis

    Metzingen, 72555

  • Praxis Kutenhausen

    Minden, 32425

  • Krankenhaus Bethanien

    Moers, 47441

  • Kardiologische Praxis Dr. Schön

    Mühldorf, 84453

  • Evangelisches Krankenhaus Mülheim

    Mülheim, 45468

  • Kardiologie am Rotkreuzplatz

    München, 80634

  • Gemeinschaftspraxis Dres. Wauer / Windstetter

    München, 80799

  • Kardiologische Praxis Dr. Herholz

    München, 80809

  • Klinikum Augustinum München

    München, 81375

  • Praxis Dres. Böhme/Linke

    München, 81667

  • Kardiologische Praxis Dr. Muradi

    Münster, 29633

  • Universitätsklinikum Münster

    Münster, 48149

  • Praxis für Kardiologie Dr. med. Hewing

    Münster, 48151

  • Städtisches Khs Lukas

    Neuss, 41472

  • Kardiologische Praxis Nienburg

    Nienburg, 31582

  • Klinikum Nürnberg Süd

    Nuremberg, 90471

  • Kardiologische Praxis Dr. Gumbrecht

    Ochtrup, 48607

  • Kardiologische Praxis Dr. Hassler

    Plauen, 8523

  • Kardiologische Praxis Dr. Wiethölter

    Radebeul, 01445

  • Praxis für Kardiologie Ratingen

    Ratingen, 40878

  • Praxis Dr. Fröhlich

    Ratingen, 40885

  • DRK Krankenhaus Mölln-Ratzeburg

    Ratzeburg, 23909

  • Ambulantes Cardiovaskuläres Centrum

    Ravensburg, 88212

  • Gemeinschaftspraxis Dr. Weber/Dr. Feja

    Recklinghausen, 45657

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Khs St. Adolf Stift

    Reinbek, 21465

  • Praxis Dr. Hein

    Reinbek, 21465

  • Kardiologische Praxis Dr. Kleinz

    Remscheid, 42853

  • Praxis Dr. Nebel

    Rheine, 48429

  • Praxis Dr. Kestermann

    Rheine, 48431

  • Kardiologische Praxis Dr. Figura

    Rinteln, 31737

  • Praxis Dr. Ebeling

    Schönefeld, 12529

  • Kardiologische Praxis Dr. Heinze

    Schwerte, 58239

  • Praxisgemeinschaft Cardio-Soest

    Soest, 59494

  • Facharztzentrum Sonneberg

    Sonneberg, 96515

  • Kreiskrankenhaus Stollberg GmbH

    Stollberg, 09366

  • Kardiologische Praxis Dr. Birkenhagen

    Stollberg, 9366

  • Klinikum Uelzen GmbH

    Uelzen, 29525

  • Herzklinik Ulm Dr. Haerer und Partner

    Ulm, 89077

  • Zentrum für Innere Medizin Uni Ulm

    Ulm, 89081

  • Katharinen Hospital Unna

    Unna, 59423

  • Kardiologische Praxis Dr. Burkhard-Meier

    Viersen, 41747

  • Praxis Dr. Gerritsen

    Waldkraiburg, 84478

  • Fachkliniken Wangen

    Wangen, 88239

  • Stiftungsklinik Weißenhorn

    Weißenhorn, 89264

  • Kardiologisch angiologische Gemeinschaftspraxis

    Wiesbaden, 65183

  • Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

    Wiesbaden, 65183

  • Kardiologische Praxis Dr. Vrettos

    Witten, 58452

  • Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

    Worms, 67547

  • Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

    Würzburg, 97080

  • Universitätsklinikum Würzburg

    Würzburg, 97080

  • Evangel. Khs Zweibrücken

    Zweibrücken, 66482

Other trials in Germany

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Rivercity Private Hospital

    Auchenflower, Queensland, 4066

  • Melbourne Sleep Disorders Centre

    East Melbourne, Victoria 3002, 3002

  • Baker IDI Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • St Vincents and Mercy Private Hospital

    Melbourne, Victoria, 3065

  • Hollywood Private Hospital (CVS)

    Nedlands, Western Australia, 6009

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure

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.

Read the 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.

Keywords
chronic heart failure, heart failure, hf, sleep-disordered breathing, sdb, nyha, lvef, cheyne stokes, central sleep apnoea, sleep apnoea
Medical subject headings
Heart Failure, Ventricular Dysfunction, Left, Sleep Apnea Syndromes, Cheyne-Stokes Respiration, Sleep Apnea, Central

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of SDB in Chronic HF Patients

    SDB= Sleep disordered breathing; HF= Heart failure

    Measured: 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)

  1. Left Ventricular Ejection Fraction

    Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole

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

  2. Age

    Age years

    Measured: 1-time single assessment at baseline

  3. Body Mass Index

    Measured: 1-time single assessment at baseline

  4. Male Gender

    Measured: 1-time single assessment at baseline

  5. NYHA Class ≥III

    New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.

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

  6. Ischemic Etiology

    Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.

    Measured: 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.

  7. Atrial Fibrillation

    Measured: 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records

  8. Nocturnal Dyspnea

    Measured: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records

  9. Nocturia ≥3 Times/Night

    Measured: 1-time: At baseline nocturia was assessed 1 time (anamnesis)

  10. Apnoea-Hypopnea-Index

    Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep

    Measured: 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility

  11. Oxygen Desaturation Index

    Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.

    Measured: 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility

  12. Mean SpO2

    Saturation of oxygen

    Measured: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility

  13. Min SpO2

    Lowest Saturation with oxygen

    Measured: 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility

  14. Medication ACE Inhibitors and/ARBs

    ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker

    Measured: 1-time: At baseline medication was assessed 1 time (anamnesis)

  15. Beta-blocker

    Measured: 1-time: At baseline medication was assessed 1 time (anamnesis)

  16. Diuretics

    Measured: 1-time: At baseline medication was assessed 1 time (anamnesis)

  17. Digitalis

    Measured: 1-time: At baseline medication was assessed 1 time (anamnesis)

  18. Aldosterone Antagonists

    Measured: 1-time: At baseline medication was assessed 1 time (anamnesis)

  19. Male Gender as Predictor for SDB in Chronic HF

    From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure

    Measured: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

  20. Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF

    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure

    Measured: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

  21. Ischemic Etiology as Predictor for SDB in Chronic HF

    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure

    Measured: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

  22. NYHA Class >= III as Predictor for SDB in Chronic HF

    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure

    Measured: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2011 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,876 participants (actual)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500759
Sponsor's protocol ID
001
Acronym
SchlaHF
Status last verified
May 2020
First submitted
23 Dec 2011
Last updated
9 Jul 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 24716484

  • 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.

    PubMed 26682790

  • 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.

    PubMed 29187390

Questions about this trial

What is this clinical trial studying?

An observational study of Congestive Heart Failure and Left Ventricular Systolic Dysfunction, run by ResMed at 199 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in Germany, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of SDB in Chronic HF Patients (time frame: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500759, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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