Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
- Conditions
- Left Ventricular Systolic DysfunctionCongestive Heart Failure
- Registration Number
- NCT01500759
- Lead Sponsor
- ResMed
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6876
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of SDB in Chronic HF Patients 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility SDB= Sleep disordered breathing; HF= Heart failure
- Secondary Outcome Measures
Name Time Method Nocturia ≥3 Times/Night 1-time: At baseline nocturia was assessed 1 time (anamnesis) Apnoea-Hypopnea-Index 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep
Male Gender 1-time single assessment at baseline Left Ventricular Ejection Fraction 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole
NYHA Class ≥III At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records 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.
Atrial Fibrillation 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records Body Mass Index 1-time single assessment at baseline Mean SpO2 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility Saturation of oxygen
Min SpO2 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility Lowest Saturation with oxygen
Diuretics 1-time: At baseline medication was assessed 1 time (anamnesis) NYHA Class >= III as Predictor for SDB in Chronic HF 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) 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
Ischemic Etiology 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records. 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.
Nocturnal Dyspnea 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records Medication ACE Inhibitors and/ARBs 1-time: At baseline medication was assessed 1 time (anamnesis) ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
Male Gender as Predictor for SDB in Chronic HF 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) 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
Oxygen Desaturation Index 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) 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
Beta-blocker 1-time: At baseline medication was assessed 1 time (anamnesis) Digitalis 1-time: At baseline medication was assessed 1 time (anamnesis) Aldosterone Antagonists 1-time: At baseline medication was assessed 1 time (anamnesis) Ischemic Etiology as Predictor for SDB in Chronic HF 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) 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
Age 1-time single assessment at baseline Age years
Trial Locations
- Locations (199)
DRK Krankenhaus
🇩🇪Alzey, Germany
Praxis Dr. Frieske
🇩🇪Aachen, Germany
Melbourne Sleep Disorders Centre
🇦🇺East Melbourne, Victoria, Australia
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Oberlausitz-Kliniken gGmbH
🇩🇪Bautzen, Germany
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
🇩🇪Marburg, Germany
Kardiologische Praxis Nienburg
🇩🇪Nienburg, Germany
Klinikum Nürnberg Süd
🇩🇪Nürnberg, Germany
Hollywood Private Hospital (CVS)
🇦🇺Nedlands, Western Australia, Australia
Praxis Dr. Tekiyeh
🇩🇪Essen, Germany
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Rivercity Private Hospital
🇦🇺Auchenflower, Queensland, Australia
Praxis Dr. Bauer
🇩🇪Bad Mergentheim, Germany
HDZ NRW
🇩🇪Bad Oeynhausen, Germany
Mediclin Rehazentrum Spreewald
🇩🇪Burg/Spreewald, Germany
Kardiologie-Gemeinschaftspraxis Dortmund
🇩🇪Dortmund, Germany
Kardiologische Praxis Dr. Wetzel
🇩🇪Dortmund, Germany
goMedus Gesundheitszentrum
🇩🇪Düsseldorf, Germany
Khs Florence-Nightingale
🇩🇪Duesseldorf, Germany
Florence-Nightingale Krankenhaus
🇩🇪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
Kardiologische Praxis Dr. Cord Müller
🇩🇪Essen, Germany
Kardiologie Praxis Dr. Bonnekamp
🇩🇪Essen, Germany
Gemeinschaftspraxis für Herz & Gefäße
🇩🇪Mannheim, Germany
Universitätsklinik Mannheim-Kardiologie
🇩🇪Mannheim, Germany
Fachkliniken Wangen
🇩🇪Wangen, Germany
Kardiologisch angiologische Gemeinschaftspraxis
🇩🇪Wiesbaden, Germany
Charité Campus Virchow Klinikum
🇩🇪Berlin, Germany
Gemeinschaftspraxis Weiß/ Dr. Heesing
🇩🇪Arnsberg, Germany
Klinik Lazariterhof
🇩🇪Bad Krozingen, Germany
Herzzentrum Brandenburg
🇩🇪Bernau, Germany
St.-Josephs-Hospital
🇩🇪Bochum, Germany
Kardiologische Praxis Dr. Staubach
🇩🇪Bochum, Germany
Kardiologische Praxis Dr. Lodde
🇩🇪Dortmund, Germany
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Cardiopraxis Ingelheim
🇩🇪Ingelheim am Rhein, Rheinland-Pfalz, Germany
Kardiologische Praxis Dr. Isbruch
🇩🇪Castrop-Rauxel, Germany
Kardiologische Praxis Dr. Stroh
🇩🇪Bad Wurzach, Germany
Kardiopraxis Rheinberg
🇩🇪Bergisch Gladbach, Germany
Universitätsklinikum Bergmannsheil
🇩🇪Bochum, Germany
Augusta Krankenanstalten Bochum
🇩🇪Bochum, Germany
Kardiologie Kemnade
🇩🇪Bochum, Germany
Kardiologie Bühl
🇩🇪Brühl, Germany
MVZ am Küchwald
🇩🇪Chemnitz, Germany
Fachkrankenhaus Coswig
🇩🇪Coswig, Germany
Praxis Dr. Hecker
🇩🇪Dortmund, Germany
Kardiologie - Gemeinschaftspraxis Dortmund
🇩🇪Dortmund, Germany
Gemeinschaftpraxis Dres. Schmidt/Gronke
🇩🇪Dresden, Germany
Baker IDI Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Herzzentrum Bad Krozingen
🇩🇪Bad Krozingen, Germany
Kardiologie Gemeinschaftspraxis Dr. Tenholt
🇩🇪Bochum, Germany
Praxis für Kardiologie Bonn
🇩🇪Bonn, Germany
Gemeinschaftspraxis Kardiologie
🇩🇪Bottrop, Germany
Gemeinschaftspraxis Dres. Tinnefeld
🇩🇪Bottrop, Germany
Carl-Thiem-Klinikum gGmbH
🇩🇪Cottbus, Germany
Kardiologische Praxis Dr. Dröse
🇩🇪Dortmund, Germany
Herzzentrum Universität Dresden
🇩🇪Dresden, Germany
Ruhrlandklinik Essen
🇩🇪Essen, Germany
Praxis Gemeinschaft Frille
🇩🇪Berlin, Germany
Praxis Westend
🇩🇪Berlin, Germany
Zentralklinikum Bad Berka
🇩🇪Bad Berka, Germany
Praxis für Lunge,Herz und Schlaf
🇩🇪Bielefeld, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Kardiologische Praxis Marschner
🇩🇪Bonn, Germany
Gemeinschaftspraxis Kardiologie Dr. Becker
🇩🇪Castrop-Rauxel, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Kardiologische Praxis Dr. Golling
🇩🇪Dortmund, Germany
Charité Campus Mitte CCM
🇩🇪Berlin, Germany
Charité Campus Mitte
🇩🇪Berlin, Germany
POLIKUM Friedenau
🇩🇪Berlin, Germany
Gemeinschaftspraxis Groß-Ziethener Chaussee
🇩🇪Berlin, Germany
Jüdisches Krankenhaus Berlin
🇩🇪Berlin, Germany
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
Clinical Trial Site Services
🇩🇪Dortmund, Germany
Praxis Dr. Hohensee
🇩🇪Dresden, Germany
Kardiologische Praxis Dr. Horowitz
🇩🇪Düsseldorf, Germany
Westdeutsches Herzzentrum, Universitätsklinikum Essen
🇩🇪Essen, Germany
Kardiologische Praxis Prof. Winter
🇩🇪Essen, Germany
Kardiologische Praxis Dr. Hug
🇩🇪Günzburg, Germany
Praxis Dr. Hötte
🇩🇪Hannover, Germany
Praxis Dr. Durak
🇩🇪Heidelberg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Germany
Kardiologische Praxis Dr. Raff
🇩🇪Düsseldorf, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg im Breisgau, Germany
Gemeinschaftspraxis Dres. Böhmeke/Schmidt
🇩🇪Gladbeck, Germany
Gemeinschaftspraxis Dres Leischik/Littwitz
🇩🇪Hagen, Germany
EvK Herne
🇩🇪Herne, Germany
Kardiologische Praxis Dr. Furche
🇩🇪Herne, Germany
St. Elisabeth-Hospital Herten gGmbH
🇩🇪Herten, Germany
Internistenpraxis Alstertal Hamburg
🇩🇪Hamburg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Praxis Dr. Rau
🇩🇪Essen, Germany
Kath. Kliniken Essen / Philippusstift
🇩🇪Essen, Germany
Kardiologische Praxis Dr. Kruse
🇩🇪Forst, Germany
Kardiologische Praxis Dr. Arens
🇩🇪Hagen, Germany
Gemeinschaftspraxis Dres. Subin/Lutter
🇩🇪Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
🇩🇪Essen, Germany
Elisabeth-Krankenhaus Essen
🇩🇪Essen, Germany
Gemeinschaftspraxis Dres. Guckenbiehl
🇩🇪Flonheim, Germany
CardioVasculäres Centrum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg im Breisgau, Germany
Praxis Dr. Diedrichs
🇩🇪Frechen, Germany
Kardiologische Praxis Gütersloh
🇩🇪Gütersloh, Germany
Siloah Krankenhaus
🇩🇪Hannover, Germany
Kardiologische Praxis Dr. Schröder
🇩🇪Hamburg, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Heidelberger Praxisklinik für Kardiologie
🇩🇪Heidelberg, Germany
Kardiologische Praxis Dr. Cierpka
🇩🇪Hannover, Germany
Evangelisches Krankenhaus Herne
🇩🇪Herne, Germany
Kardiologische Praxis Dr. Hartung
🇩🇪Hannover, Germany
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Praxis für Innere Medizin/Kardiologie
🇩🇪Hoyerswerda, Germany
Praxis Dr. Krater
🇩🇪Krefeld, Germany
Malteser Krankenhaus St. Hildegardis
🇩🇪Köln, Germany
Prof. Franzen Institut
🇩🇪Köln, Germany
Klinikum der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Herz-& Gefäßpraxis
🇩🇪Metzingen, Germany
Kardiologische Praxis Dr. Gumbrecht
🇩🇪Ochtrup, Germany
Gemeinschaftspraxis Dr. Weber/Dr. Feja
🇩🇪Recklinghausen, Germany
Kardiologische Praxis Dr. Kleinz
🇩🇪Remscheid, Germany
Gemeinschaftspraxis Dr. Bruch
🇩🇪Herne, Germany
Kardiologische Praxis Dr. Siegfried Frickel
🇩🇪Kempen, Germany
Kardiologische Praxis Dr. Schlichting
🇩🇪Herne, Germany
Klinikum der Universität zu Köln- Herzzentrum
🇩🇪Köln, Germany
Praxis Dr. Anselm Bäumer
🇩🇪Köln, Germany
Klinikum Dahme-Spreewald GmbH
🇩🇪Königs Wusterhausen, Germany
Helios Krankenhaus Leisnig
🇩🇪Leisnig, Germany
Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
🇩🇪Mannheim, Germany
Kardiologische Praxis Dr. Schön
🇩🇪Mühldorf, Germany
Klinikum Augustinum München
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Gemeinschaftspraxis Dres. Dobler/Turin
🇩🇪Karlstadt, Germany
Ambulantes Herzzentrum Kassel
🇩🇪Kassel, Germany
Helios Klinikum Krefeld
🇩🇪Krefeld, Germany
Kardiologische Praxis Dr. Fritsch
🇩🇪Köln, Germany
Kardiologische Praxis Dr. Faber
🇩🇪Lindlar, Germany
Praxis Dr. Schnabel
🇩🇪Meissen, Germany
Gemeinschaftspraxis Dr. Jocham
🇩🇪Memmingen, Germany
Klinik Kitzinger Land
🇩🇪Kitzingen, Germany
Universitätsklinikum Leipzig-Herzzentrum
🇩🇪Leipzig, Germany
Gemeinschaftspraxis Dr. Hilgedieck/Sava
🇩🇪Lengerich, Germany
Gemeinschaftspraxis Dres. Brandt / Jakobs
🇩🇪Mannheim, Germany
St.-Vinzenz Hospital
🇩🇪Köln, Germany
Universitätsklinikum Köln-Herzzentrum
🇩🇪Köln, Germany
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
🇩🇪Köln, Germany
Ärztezentrum Holthausen-Biene
🇩🇪Lingen, Germany
Kardiologische Praxis Ludwigsburg
🇩🇪Ludwigsburg, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
🇩🇪Lübeck, Germany
Praxis Kutenhausen
🇩🇪Minden, Germany
Krankenhaus Bethanien
🇩🇪Moers, Germany
Evangelisches Krankenhaus Mülheim
🇩🇪Mülheim an der Ruhr, Germany
Gemeinschaftspraxis Dres. Wauer / Windstetter
🇩🇪München, Germany
Praxis für Kardiologie Dr. med. Menz
🇩🇪Menden, Germany
Kardiologische Praxis Dr. Herholz
🇩🇪München, Germany
Praxis Dres. Böhme/Linke
🇩🇪München, Germany
Kardiologische Praxis Dr. Hassler
🇩🇪Plauen, Germany
Khs St. Adolf Stift
🇩🇪Reinbek, Germany
Praxis Dr. Nebel
🇩🇪Rheine, Germany
Kardiologische Praxis Dr. Heinze
🇩🇪Schwerte, Germany
Kardiologie am Rotkreuzplatz
🇩🇪München, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Praxis Dr. Hein
🇩🇪Reinbek, Germany
Praxis Dr. Ebeling
🇩🇪Schönefeld, Germany
Praxisgemeinschaft Cardio-Soest
🇩🇪Soest, Germany
Kardiologische Praxis Dr. Muradi
🇩🇪Münster, Germany
Ambulantes Cardiovaskuläres Centrum
🇩🇪Ravensburg, Germany
Comprehensive Heart Failure Center, Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Praxis für Kardiologie Dr. med. Hewing
🇩🇪Münster, Germany
Städtisches Khs Lukas
🇩🇪Neuss, Germany
Kardiologische Praxis Dr. Wiethölter
🇩🇪Radebeul, Germany
Praxis für Kardiologie Ratingen
🇩🇪Ratingen, Germany
Praxis Dr. Fröhlich
🇩🇪Ratingen, Germany
DRK Krankenhaus Mölln-Ratzeburg
🇩🇪Ratzeburg, Germany
Praxis Dr. Kestermann
🇩🇪Rheine, Germany
Praxis Dr. Gerritsen
🇩🇪Waldkraiburg, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Stiftungsklinik Weißenhorn
🇩🇪Weißenhorn, Germany
Kardiologische Praxis Dr. Figura
🇩🇪Rinteln, Germany
Kardiologische Praxis Dr. Birkenhagen
🇩🇪Stollberg, Germany
Herzklinik Ulm Dr. Haerer und Partner
🇩🇪Ulm, Germany
Kardiologische Praxis Dr. Burkhard-Meier
🇩🇪Viersen, Germany
Facharztzentrum Sonneberg
🇩🇪Sonneberg, Germany
Kreiskrankenhaus Stollberg GmbH
🇩🇪Stollberg, Germany
Kardiologische Praxis Dr. Vrettos
🇩🇪Witten, Germany
Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
🇩🇪Worms, Germany
Evangel. Khs Zweibrücken
🇩🇪Zweibrücken, Germany
Klinikum Uelzen GmbH
🇩🇪Uelzen, Germany
Zentrum für Innere Medizin Uni Ulm
🇩🇪Ulm, Germany
Katharinen Hospital Unna
🇩🇪Unna, Germany
Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck
🇩🇪Wiesbaden, Germany
St Vincents and Mercy Private Hospital
🇦🇺Melbourne, Victoria, Australia