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

Congestive Heart Failure Clinical Trial

— SchlaHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500759
• Other study ID #: 001
• Status: Completed
• Start date: November 2007
• Est. completion date: May 2013

Study information

• Verified date: May 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Left Ventricular Systolic Dysfunction
• Respiratory Aspiration
• Sleep Apnea Syndromes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Countries where clinical trial is conducted

Australia,  Germany, 

References & Publications (3)

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

Outcome

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)