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

June 25, 2020 updated by: ResMed

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

6876

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Rivercity Private Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Melbourne Sleep Disorders Centre
      • Melbourne, Victoria, Australia, 3004
        • Baker IDI Heart and Diabetes Institute
      • Melbourne, Victoria, Australia, 3065
        • St Vincents and Mercy Private Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Hollywood Private Hospital (CVS)
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen
      • Aachen, Germany, 52062
        • Praxis Dr. Frieske
      • Alzey, Germany, 55232
        • DRK Krankenhaus
      • Arnsberg, Germany, 59821
        • Gemeinschaftspraxis Weiß/ Dr. Heesing
      • Bad Berka, Germany, 99437
        • Zentralklinikum Bad berka
      • Bad Krozingen, Germany, 79189
        • Herzzentrum Bad Krozingen
      • Bad Krozingen, Germany, 79189
        • Klinik Lazariterhof
      • Bad Mergentheim, Germany, 97980
        • Praxis Dr. Bauer
      • Bad Oeynhausen, Germany, 32545
        • HDZ NRW
      • Bad Wurzach, Germany, 88410
        • Kardiologische Praxis Dr. Stroh
      • Bautzen, Germany, 02625
        • Oberlausitz-Kliniken gGmbH
      • Bergisch Gladbach, Germany, 51465
        • Kardiopraxis Rheinberg
      • Berlin, Germany, 12683
        • Unfallkrankenhaus Berlin
      • Berlin, Germany, 10117
        • Charite Campus Mitte
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum
      • Berlin, Germany, 13353
        • Charite Campus Virchow Klinikum
      • Berlin, Germany, 10117
        • Charité Campus Mitte CCM
      • Berlin, Germany, 10178
        • Praxis Gemeinschaft Frille
      • Berlin, Germany, 12157
        • POLIKUM Friedenau
      • Berlin, Germany, 12355
        • Gemeinschaftspraxis Groß-Ziethener Chaussee
      • Berlin, Germany, 13347
        • Judisches Krankenhaus Berlin
      • Berlin, Germany, 14050
        • Praxis Westend
      • Bernau, Germany, 16321
        • Herzzentrum Brandenburg
      • Bielefeld, Germany, 33617
        • Praxis für Lunge,Herz und Schlaf
      • Bochum, Germany, 44787
        • Kardiologie Gemeinschaftspraxis Dr. Tenholt
      • Bochum, Germany, 44789
        • Universitätsklinikum Bergmannsheil
      • Bochum, Germany, 44791
        • Augusta Krankenanstalten Bochum
      • Bochum, Germany, 44791
        • St.-Josephs-Hospital
      • Bochum, Germany, 44797
        • Kardiologie Kemnade
      • Bochum, Germany, 44866
        • Kardiologische Praxis Dr. Staubach
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Bonn, Germany, 53127
        • Praxis für Kardiologie Bonn
      • Bonn, Germany, 53225
        • Kardiologische Praxis Marschner
      • Bottrop, Germany, 46236
        • Gemeinschaftspraxis Kardiologie
      • Bottrop, Germany, 46240
        • Gemeinschaftspraxis Dres. Tinnefeld
      • Brühl, Germany, 50321
        • Kardiologie Bühl
      • Burg/Spreewald, Germany, 03096
        • Mediclin Rehazentrum Spreewald
      • Castrop-Rauxel, Germany, 44575
        • Gemeinschaftspraxis Kardiologie Dr. Becker
      • Castrop-Rauxel, Germany, 44577
        • Kardiologische Praxis Dr. Isbruch
      • Chemnitz, Germany, 09113
        • MVZ am Küchwald
      • Coburg, Germany, 96450
        • Klinikum Coburg GmbH
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig
      • Cottbus, Germany, 03042
        • Carl-Thiem-Klinikum gGmbH
      • Dortmund, Germany, 44137
        • Klinikum Dortmund gGmbH
      • Dortmund, Germany, 44135
        • Praxis Dr. Hecker
      • Dortmund, Germany, 44137
        • Kardiologie - Gemeinschaftspraxis Dortmund
      • Dortmund, Germany, 44137
        • Kardiologie-Gemeinschaftspraxis Dortmund
      • Dortmund, Germany, 44137
        • Kardiologische Praxis Dr. Golling
      • Dortmund, Germany, 44141
        • Clinical Trial Site Services
      • Dortmund, Germany, 44141
        • Kardiologische Praxis Dr. Wetzel
      • Dortmund, Germany, 44147
        • Kardiologische Praxis Dr. Lodde
      • Dortmund, Germany, 44263
        • Kardiologische Praxis Dr. Dröse
      • Dresden, Germany, 01099
        • Facharztzentrum Dresden-Neustadt GbR
      • Dresden, Germany, 01219
        • Gemeinschaftpraxis Dres. Schmidt/Gronke
      • Dresden, Germany, 01277
        • Praxis Dr. Hohensee
      • Dresden, Germany, 01307
        • Herzzentrum Universität Dresden
      • Duesseldorf, Germany, 40489
        • Khs Florence-Nightingale
      • Düsseldorf, Germany, 40212
        • goMedus Gesundheitszentrum
      • Düsseldorf, Germany, 40215
        • Kardiologische Praxis Dr. Horowitz
      • Düsseldorf, Germany, 40237
        • Kardiologische Praxis Dr. Raff
      • Düsseldorf, Germany, 40489
        • Florence-Nightingale Krankenhaus
      • Düsseldorf, Germany, 40545
        • Kardiologie Oberkassel
      • Düsseldorf, Germany, 40597
        • Gemeinschaftspraxis PD Dr. Lankisch
      • Emmendingen, Germany, 79312
        • Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt-Kardiologie
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt-Schlafmedizin
      • Erlangen, Germany, 91054
        • Universitatsklinikum Erlangen
      • Essen, Germany, 45239
        • Ruhrlandklinik Essen
      • Essen, Germany, 45138
        • Elisabeth-Krankenhaus Essen
      • Essen, Germany, 45122
        • Westdeutsches Herzzentrum, Universitätsklinikum Essen
      • Essen, Germany, 45131
        • Kardiologische Praxis Dr. Cord Müller
      • Essen, Germany, 45131
        • Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch
      • Essen, Germany, 45134
        • Kardiologische Praxis Prof. Winter
      • Essen, Germany, 45136
        • Kardiologie Praxis Dr. Bonnekamp
      • Essen, Germany, 45136
        • Praxis Dr. Tekiyeh
      • Essen, Germany, 45276
        • Praxis Dr. Rau
      • Essen, Germany, 45359
        • Kath. Kliniken Essen / Philippusstift
      • Flonheim, Germany, 55237
        • Gemeinschaftspraxis Dres. Guckenbiehl
      • Forst, Germany, 03149
        • Kardiologische Praxis Dr. Kruse
      • Frankfurt, Germany, 60389
        • CardioVasculäres Centrum Frankfurt
      • Frechen, Germany, 50226
        • Praxis Dr. Diedrichs
      • Freiburg im Breisgau, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Gladbeck, Germany, 45964
        • Gemeinschaftspraxis Dres. Böhmeke/Schmidt
      • Günzburg, Germany, 89312
        • Kardiologische Praxis Dr. Hug
      • Gütersloh, Germany, 33330
        • Kardiologische Praxis Gütersloh
      • Hagen, Germany, 58095
        • Gemeinschaftspraxis Dres Leischik/Littwitz
      • Hagen, Germany, 58095
        • Kardiologische Praxis Dr. Arens
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 22291
        • Asklepios Klinik Barmbek
      • Hamburg, Germany, 20095
        • Gemeinschaftspraxis Dres. Subin/Lutter
      • Hamburg, Germany, 22399
        • Internistenpraxis Alstertal Hamburg
      • Hamburg, Germany, 22765
        • Kardiologische Praxis Dr. Schröder
      • Hannover, Germany, 30159
        • Kardiologische Praxis Dr. Cierpka
      • Hannover, Germany, 30449
        • Praxis Dr. Hötte
      • Hannover, Germany, 30449
        • Siloah Krankenhaus
      • Hannover, Germany, 30559
        • Kardiologische Praxis Dr. Hartung
      • Heidelberg, Germany, 69120
        • UniversitatsKlinikum Heidelberg
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH
      • Heidelberg, Germany, 69115
        • Heidelberger Praxisklinik für Kardiologie
      • Heidelberg, Germany, 69115
        • Praxis Dr. Durak
      • Herne, Germany, 44623
        • EVK Herne
      • Herne, Germany, 44623
        • Evangelisches Krankenhaus Herne
      • Herne, Germany, 44623
        • Kardiologische Praxis Dr. Furche
      • Herne, Germany, 44629
        • Gemeinschaftspraxis Dr. Bruch
      • Herne, Germany, 44649
        • Kardiologische Praxis Dr. Schlichting
      • Herten, Germany, 45699
        • St. Elisabeth-Hospital Herten gGmbH
      • Hoyerswerda, Germany, 02977
        • Praxis für Innere Medizin/Kardiologie
      • Karlstadt, Germany, 97753
        • Gemeinschaftspraxis Dres. Dobler/Turin
      • Kassel, Germany, 34121
        • Ambulantes Herzzentrum Kassel
      • Kempen, Germany, 47906
        • Kardiologische Praxis Dr. Siegfried Frickel
      • Kitzingen, Germany, 97318
        • Klinik Kitzinger Land
      • Krefeld, Germany, 47805
        • Helios Klinikum Krefeld
      • Krefeld, Germany, 47799
        • Praxis Dr. Krater
      • Köln, Germany, 50733
        • St.-Vinzenz Hospital
      • Köln, Germany, 50737
        • Kardiologische Praxis Dr. Fritsch
      • Köln, Germany, 50931
        • Malteser Krankenhaus St. Hildegardis
      • Köln, Germany, 50937
        • Klinikum der Universität zu Köln- Herzzentrum
      • Köln, Germany, 50937
        • Prof. Franzen Institut
      • Köln, Germany, 50937
        • Universitätsklinikum Köln-Herzzentrum
      • Köln, Germany, 51065
        • Praxis Dr. Anselm Bäumer
      • Köln, Germany, 51105
        • Gemeinschaftspraxis Dres. Gysan/Heinzler/May
      • Königs Wusterhausen, Germany, 15711
        • Klinikum Dahme-Spreewald GmbH
      • Leipzig, Germany, 04289
        • Universitätsklinikum Leipzig-Herzzentrum
      • Leisnig, Germany, 04703
        • Helios Krankenhaus Leisnig
      • Lengerich, Germany, 49525
        • Gemeinschaftspraxis Dr. Hilgedieck/Sava
      • Lindlar, Germany, 51784
        • Kardiologische Praxis Dr. Faber
      • Lingen, Germany, 49808
        • Ärztezentrum Holthausen-Biene
      • Ludwigsburg, Germany, 71634
        • Kardiologische Praxis Ludwigsburg
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
      • Mainz, Germany, 55101
        • Klinikum der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68161
        • Gemeinschaftspraxis Dres. Heifer/Loster/Schernus
      • Mannheim, Germany, 68161
        • Gemeinschaftspraxis für Herz & Gefäße
      • Mannheim, Germany, 68167
        • Universitätsklinik Mannheim-Kardiologie
      • Mannheim, Germany, 68305
        • Gemeinschaftspraxis Dres. Brandt / Jakobs
      • Marburg, Germany, 35043
        • Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie
      • Meissen, Germany, 01662
        • Praxis Dr. Schnabel
      • Memmingen, Germany, 87700
        • Gemeinschaftspraxis Dr. Jocham
      • Menden, Germany, 58706
        • Praxis Für Kardiologie Dr. med. Menz
      • Metzingen, Germany, 72555
        • Herz-& Gefäßpraxis
      • Minden, Germany, 32425
        • Praxis Kutenhausen
      • Moers, Germany, 47441
        • Krankenhaus Bethanien
      • Mühldorf, Germany, 84453
        • Kardiologische Praxis Dr. Schön
      • Mülheim an der Ruhr, Germany, 45468
        • Evangelisches Krankenhaus Mülheim
      • München, Germany, 80634
        • Kardiologie am Rotkreuzplatz
      • München, Germany, 80799
        • Gemeinschaftspraxis Dres. Wauer / Windstetter
      • München, Germany, 80809
        • Kardiologische Praxis Dr. Herholz
      • München, Germany, 81375
        • Klinikum Augustinum München
      • München, Germany, 81667
        • Praxis Dres. Böhme/Linke
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Münster, Germany, 29633
        • Kardiologische Praxis Dr. Muradi
      • Münster, Germany, 48151
        • Praxis für Kardiologie Dr. med. Hewing
      • Neuss, Germany, 41472
        • Städtisches Khs Lukas
      • Nienburg, Germany, 31582
        • Kardiologische Praxis Nienburg
      • Nürnberg, Germany, 90471
        • Klinikum Nurnberg Sud
      • Ochtrup, Germany, 48607
        • Kardiologische Praxis Dr. Gumbrecht
      • Plauen, Germany, 8523
        • Kardiologische Praxis Dr. Hassler
      • Radebeul, Germany, 01445
        • Kardiologische Praxis Dr. Wiethölter
      • Ratingen, Germany, 40878
        • Praxis für Kardiologie Ratingen
      • Ratingen, Germany, 40885
        • Praxis Dr. Fröhlich
      • Ratzeburg, Germany, 23909
        • DRK Krankenhaus Mölln-Ratzeburg
      • Ravensburg, Germany, 88212
        • Ambulantes Cardiovaskuläres Centrum
      • Recklinghausen, Germany, 45657
        • Gemeinschaftspraxis Dr. Weber/Dr. Feja
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Reinbek, Germany, 21465
        • Khs St. Adolf Stift
      • Reinbek, Germany, 21465
        • Praxis Dr. Hein
      • Remscheid, Germany, 42853
        • Kardiologische Praxis Dr. Kleinz
      • Rheine, Germany, 48429
        • Praxis Dr. Nebel
      • Rheine, Germany, 48431
        • Praxis Dr. Kestermann
      • Rinteln, Germany, 31737
        • Kardiologische Praxis Dr. Figura
      • Schwerte, Germany, 58239
        • Kardiologische Praxis Dr. Heinze
      • Schönefeld, Germany, 12529
        • Praxis Dr. Ebeling
      • Soest, Germany, 59494
        • Praxisgemeinschaft Cardio-Soest
      • Sonneberg, Germany, 96515
        • Facharztzentrum Sonneberg
      • Stollberg, Germany, 09366
        • Kreiskrankenhaus Stollberg GmbH
      • Stollberg, Germany, 9366
        • Kardiologische Praxis Dr. Birkenhagen
      • Uelzen, Germany, 29525
        • Klinikum Uelzen GmbH
      • Ulm, Germany, 89077
        • Herzklinik Ulm Dr. Haerer und Partner
      • Ulm, Germany, 89081
        • Zentrum für Innere Medizin Uni Ulm
      • Unna, Germany, 59423
        • Katharinen Hospital Unna
      • Viersen, Germany, 41747
        • Kardiologische Praxis Dr. Burkhard-Meier
      • Waldkraiburg, Germany, 84478
        • Praxis Dr. Gerritsen
      • Wangen, Germany, 88239
        • Fachkliniken Wangen
      • Weißenhorn, Germany, 89264
        • Stiftungsklinik Weißenhorn
      • Wiesbaden, Germany, 65183
        • Kardiologisch angiologische Gemeinschaftspraxis
      • Wiesbaden, Germany, 65183
        • Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck
      • Witten, Germany, 58452
        • Kardiologische Praxis Dr. Vrettos
      • Worms, Germany, 67547
        • Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
      • Würzburg, Germany, 97080
        • Comprehensive Heart Failure Center, Universitätsklinikum Würzburg
      • Zweibrücken, Germany, 66482
        • Evangel. Khs Zweibrücken
    • Rheinland-Pfalz
      • Ingelheim am Rhein, Rheinland-Pfalz, Germany, 55218
        • Cardiopraxis Ingelheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction
Time Frame: 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
1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution
Age
Time Frame: 1-time single assessment at baseline
Age years
1-time single assessment at baseline
Body Mass Index
Time Frame: 1-time single assessment at baseline
1-time single assessment at baseline
Male Gender
Time Frame: 1-time single assessment at baseline
1-time single assessment at baseline
NYHA Class ≥III
Time Frame: 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.
At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records
Ischemic Etiology
Time Frame: 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.
1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.
Atrial Fibrillation
Time Frame: 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records
1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records
Nocturnal Dyspnea
Time Frame: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
Nocturia ≥3 Times/Night
Time Frame: 1-time: At baseline nocturia was assessed 1 time (anamnesis)
1-time: At baseline nocturia was assessed 1 time (anamnesis)
Apnoea-Hypopnea-Index
Time Frame: 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
1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility
Oxygen Desaturation Index
Time Frame: 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.
1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility
Mean SpO2
Time Frame: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility
Saturation of oxygen
1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility
Min SpO2
Time Frame: 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility
Lowest Saturation with oxygen
1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility
Medication ACE Inhibitors and/ARBs
Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
1-time: At baseline medication was assessed 1 time (anamnesis)
Beta-blocker
Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
1-time: At baseline medication was assessed 1 time (anamnesis)
Diuretics
Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
1-time: At baseline medication was assessed 1 time (anamnesis)
Digitalis
Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
1-time: At baseline medication was assessed 1 time (anamnesis)
Aldosterone Antagonists
Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis)
1-time: At baseline medication was assessed 1 time (anamnesis)
Male Gender as Predictor for SDB in Chronic HF
Time Frame: 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
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF
Time Frame: 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
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Ischemic Etiology as Predictor for SDB in Chronic HF
Time Frame: 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
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
NYHA Class >= III as Predictor for SDB in Chronic HF
Time Frame: 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
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Erland Erdmann, Prof, Klinikum der Universität zu Köln
  • Principal Investigator: Helmut Teschler, Prof, Ruhrlandklinik Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 23, 2011

First Submitted That Met QC Criteria

December 23, 2011

First Posted (Estimate)

December 28, 2011

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

May 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congestive Heart Failure

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