Congestive Heart Failure Clinical Trial
— SchlaHFOfficial title:
Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
NCT number | NCT01500759 |
Other study ID # | 001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2007 |
Est. completion date | May 2013 |
Verified date | May 2020 |
Source | ResMed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 6876 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Rivercity Private Hospital | Auchenflower | Queensland |
Australia | Melbourne Sleep Disorders Centre | East Melbourne | Victoria |
Australia | Baker IDI Heart and Diabetes Institute | Melbourne | Victoria |
Australia | St Vincents and Mercy Private Hospital | Melbourne | Victoria |
Australia | Hollywood Private Hospital (CVS) | Nedlands | Western Australia |
Australia | Westmead Hospital | Westmead | New South Wales |
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 | Berlin | |
Germany | Charité Campus Mitte CCM | Berlin | |
Germany | Charité Campus Virchow Klinikum | Berlin | |
Germany | Charité Campus Virchow-Klinikum | Berlin | |
Germany | Gemeinschaftspraxis Groß-Ziethener Chaussee | Berlin | |
Germany | Jüdisches Krankenhaus Berlin | Berlin | |
Germany | POLIKUM Friedenau | Berlin | |
Germany | Praxis Gemeinschaft Frille | Berlin | |
Germany | Praxis Westend | Berlin | |
Germany | Unfallkrankenhaus Berlin | Berlin | |
Germany | Herzzentrum Brandenburg | Bernau | |
Germany | Praxis für Lunge,Herz und Schlaf | Bielefeld | |
Germany | Augusta Krankenanstalten Bochum | Bochum | |
Germany | Kardiologie Gemeinschaftspraxis Dr. Tenholt | Bochum | |
Germany | Kardiologie Kemnade | Bochum | |
Germany | Kardiologische Praxis Dr. Staubach | Bochum | |
Germany | St.-Josephs-Hospital | Bochum | |
Germany | Universitätsklinikum Bergmannsheil | Bochum | |
Germany | Kardiologische Praxis Marschner | Bonn | |
Germany | Praxis für Kardiologie Bonn | Bonn | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Gemeinschaftspraxis Dres. Tinnefeld | Bottrop | |
Germany | Gemeinschaftspraxis Kardiologie | Bottrop | |
Germany | Kardiologie Bühl | Brühl | |
Germany | Mediclin Rehazentrum Spreewald | Burg/Spreewald | |
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 | Fachkrankenhaus Coswig | Coswig | |
Germany | Carl-Thiem-Klinikum gGmbH | Cottbus | |
Germany | Clinical Trial Site Services | Dortmund | |
Germany | Kardiologie - Gemeinschaftspraxis Dortmund | Dortmund | |
Germany | Kardiologie-Gemeinschaftspraxis Dortmund | Dortmund | |
Germany | Kardiologische Praxis Dr. Dröse | Dortmund | |
Germany | Kardiologische Praxis Dr. Golling | Dortmund | |
Germany | Kardiologische Praxis Dr. Lodde | Dortmund | |
Germany | Kardiologische Praxis Dr. Wetzel | Dortmund | |
Germany | Klinikum Dortmund gGmbH | Dortmund | |
Germany | Praxis Dr. Hecker | Dortmund | |
Germany | Facharztzentrum Dresden-Neustadt GbR | Dresden | |
Germany | Gemeinschaftpraxis Dres. Schmidt/Gronke | Dresden | |
Germany | Herzzentrum Universität Dresden | Dresden | |
Germany | Praxis Dr. Hohensee | Dresden | |
Germany | Khs Florence-Nightingale | Duesseldorf | |
Germany | Florence-Nightingale Krankenhaus | Düsseldorf | |
Germany | Gemeinschaftspraxis PD Dr. Lankisch | Düsseldorf | |
Germany | goMedus Gesundheitszentrum | Düsseldorf | |
Germany | Kardiologie Oberkassel | Düsseldorf | |
Germany | Kardiologische Praxis Dr. Horowitz | Düsseldorf | |
Germany | Kardiologische Praxis Dr. Raff | 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 | Elisabeth-Krankenhaus Essen | Essen | |
Germany | Kardiologie Praxis Dr. Bonnekamp | Essen | |
Germany | Kardiologische Praxis Dr. Cord Müller | Essen | |
Germany | Kardiologische Praxis Prof. Winter | Essen | |
Germany | Kath. Kliniken Essen / Philippusstift | Essen | |
Germany | Praxis Dr. Rau | Essen | |
Germany | Praxis Dr. Tekiyeh | Essen | |
Germany | Ruhrlandklinik Essen | Essen | |
Germany | Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch | Essen | |
Germany | Westdeutsches Herzzentrum, Universitätsklinikum Essen | 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 | Asklepios Klinik Barmbek | Hamburg | |
Germany | Gemeinschaftspraxis Dres. Subin/Lutter | Hamburg | |
Germany | Internistenpraxis Alstertal Hamburg | Hamburg | |
Germany | Kardiologische Praxis Dr. Schröder | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Kardiologische Praxis Dr. Cierpka | Hannover | |
Germany | Kardiologische Praxis Dr. Hartung | Hannover | |
Germany | Praxis Dr. Hötte | Hannover | |
Germany | Siloah Krankenhaus | Hannover | |
Germany | Heidelberger Praxisklinik für Kardiologie | Heidelberg | |
Germany | Praxis Dr. Durak | Heidelberg | |
Germany | Thoraxklinik Heidelberg gGmbH | Heidelberg | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Evangelisches Krankenhaus Herne | Herne | |
Germany | EvK Herne | Herne | |
Germany | Gemeinschaftspraxis Dr. Bruch | Herne | |
Germany | Kardiologische Praxis Dr. Furche | Herne | |
Germany | Kardiologische Praxis Dr. Schlichting | Herne | |
Germany | St. Elisabeth-Hospital Herten gGmbH | Herten | |
Germany | Praxis für Innere Medizin/Kardiologie | Hoyerswerda | |
Germany | Cardiopraxis Ingelheim | Ingelheim am Rhein | Rheinland-Pfalz |
Germany | Gemeinschaftspraxis Dres. Dobler/Turin | Karlstadt | |
Germany | Ambulantes Herzzentrum Kassel | Kassel | |
Germany | Kardiologische Praxis Dr. Siegfried Frickel | Kempen | |
Germany | Klinik Kitzinger Land | Kitzingen | |
Germany | Gemeinschaftspraxis Dres. Gysan/Heinzler/May | Köln | |
Germany | Kardiologische Praxis Dr. Fritsch | Köln | |
Germany | Klinikum der Universität zu Köln- Herzzentrum | Köln | |
Germany | Malteser Krankenhaus St. Hildegardis | Köln | |
Germany | Praxis Dr. Anselm Bäumer | Köln | |
Germany | Prof. Franzen Institut | Köln | |
Germany | St.-Vinzenz Hospital | Köln | |
Germany | Universitätsklinikum Köln-Herzzentrum | Köln | |
Germany | Klinikum Dahme-Spreewald GmbH | Königs Wusterhausen | |
Germany | Helios Klinikum Krefeld | Krefeld | |
Germany | Praxis Dr. Krater | 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 | Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie | Lübeck | |
Germany | Kardiologische Praxis Ludwigsburg | Ludwigsburg | |
Germany | Klinikum der Johannes Gutenberg-Universität Mainz | Mainz | |
Germany | Gemeinschaftspraxis Dres. Brandt / Jakobs | Mannheim | |
Germany | Gemeinschaftspraxis Dres. Heifer/Loster/Schernus | Mannheim | |
Germany | Gemeinschaftspraxis für Herz & Gefäße | Mannheim | |
Germany | Universitätsklinik Mannheim-Kardiologie | 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 an der Ruhr | |
Germany | Gemeinschaftspraxis Dres. Wauer / Windstetter | München | |
Germany | Kardiologie am Rotkreuzplatz | 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 | Praxis für Kardiologie Dr. med. Hewing | Münster | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Städtisches Khs Lukas | Neuss | |
Germany | Kardiologische Praxis Nienburg | Nienburg | |
Germany | Klinikum Nürnberg Süd | Nürnberg | |
Germany | Kardiologische Praxis Dr. Gumbrecht | Ochtrup | |
Germany | Kardiologische Praxis Dr. Hassler | Plauen | |
Germany | Kardiologische Praxis Dr. Wiethölter | Radebeul | |
Germany | Praxis Dr. Fröhlich | Ratingen | |
Germany | Praxis für Kardiologie Ratingen | 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. Kestermann | Rheine | |
Germany | Praxis Dr. Nebel | 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 | Kardiologische Praxis Dr. Birkenhagen | Stollberg | |
Germany | Kreiskrankenhaus Stollberg GmbH | 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 |
Lead Sponsor | Collaborator |
---|---|
ResMed |
Australia, Germany,
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 Hear — View Citation
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. 2 — View Citation
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 reg — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution | |
Secondary | Age | Age years | 1-time single assessment at baseline | |
Secondary | Body Mass Index | 1-time single assessment at baseline | ||
Secondary | Male Gender | 1-time single assessment at baseline | ||
Secondary | 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. | At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records | |
Secondary | 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. | 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records. | |
Secondary | 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 | ||
Secondary | Nocturnal Dyspnea | 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records | ||
Secondary | Nocturia =3 Times/Night | 1-time: At baseline nocturia was assessed 1 time (anamnesis) | ||
Secondary | 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 | 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility | |
Secondary | Oxygen Desaturation Index | Number of times that arterial blood oxygen saturation Drops by =3% from the Basic value. | 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility | |
Secondary | Mean SpO2 | Saturation of oxygen | 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility | |
Secondary | Min SpO2 | Lowest Saturation with oxygen | 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility | |
Secondary | Medication ACE Inhibitors and/ARBs | ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker | 1-time: At baseline medication was assessed 1 time (anamnesis) | |
Secondary | Beta-blocker | 1-time: At baseline medication was assessed 1 time (anamnesis) | ||
Secondary | Diuretics | 1-time: At baseline medication was assessed 1 time (anamnesis) | ||
Secondary | Digitalis | 1-time: At baseline medication was assessed 1 time (anamnesis) | ||
Secondary | Aldosterone Antagonists | 1-time: At baseline medication was assessed 1 time (anamnesis) | ||
Secondary | 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | |
Secondary | 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | |
Secondary | 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) | |
Secondary | 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 | 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) |
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