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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01500759




Trial ID
NCT01500759
Ethics application status
Date submitted
23/12/2011
Date registered
23/12/2011
Date last updated
4/08/2015

Titles & IDs
Public title
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Scientific title
Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
Secondary ID [1] 0 0
001
Universal Trial Number (UTN)
Trial acronym
SchlaHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure 0 0
Left Ventricular Systolic Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Rivercity Private Hospital - Auchenflower
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Melbourne Sleep Disorders Centre - East Melbourne
Recruitment hospital [5] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment hospital [6] 0 0
St Vincents and Mercy Private Hospital - Melbourne
Recruitment hospital [7] 0 0
Hollywood Private Hospital (CVS) - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Aachen
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Germany
State/province [2] 0 0
Alzey
Country [3] 0 0
Germany
State/province [3] 0 0
Arnsberg
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Germany
State/province [4] 0 0
Bad Berka
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Krozingen
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Mergentheim
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Oeynhausen
Country [8] 0 0
Germany
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Bad Wurzach
Country [9] 0 0
Germany
State/province [9] 0 0
Bautzen
Country [10] 0 0
Germany
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Bergisch Gladbach
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Germany
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Berlin
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Germany
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Bernau
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Germany
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Bielefeld
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Bottrop
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Germany
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Brühl
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Germany
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Burg/Spreewald
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Germany
State/province [19] 0 0
Castrop-Rauxel
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Germany
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Chemnitz
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Germany
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Coburg
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Germany
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Coswig
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Germany
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Cottbus
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Dortmund
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Dresden
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Duesseldorf
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Düsseldorf
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Emmendingen
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Erfurt
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Flonheim
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Germany
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Forst
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Frankfurt
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Germany
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Frechen
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Germany
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Freiburg im Breisgau
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Germany
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Gladbeck
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Germany
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Günzburg
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Germany
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Gütersloh
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Germany
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Hagen
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Germany
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Hamburg
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Hannover
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Herten
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Hoyerswerda
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Ingelheim
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Karlstadt
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Kassel
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Germany
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Kempen
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Kitzingen
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Germany
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Krefeld
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Germany
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Köln
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Königs Wusterhausen
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Leipzig
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Leisnig
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Lengerich
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Lindlar
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Lingen
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Ludwigsburg
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Lübeck
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Mainz
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Mannheim
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Marburg
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Meissen
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Memmingen
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Menden
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Metzingen
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Minden
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Moers
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Mühldorf
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Mülheim an der Ruhr
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München
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Münster
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Neuss
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Nienburg
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Nürnberg
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Ochtrup
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Plauen
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Radebeul
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Ratingen
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Ratzeburg
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Ravensburg
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Recklinghausen
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Regensburg
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Reinbek
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Remscheid
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Rheine
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Rinteln
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Schwerte
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Schönefeld
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Germany
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Soest
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Germany
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Sonneberg
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Stollberg
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Germany
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Uelzen
Country [96] 0 0
Germany
State/province [96] 0 0
Ulm
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Germany
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Unna
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Germany
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Viersen
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Germany
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Waldkraiburg
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Germany
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Wangen
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Germany
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Weißenhorn
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Germany
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Wiesbaden
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Germany
State/province [103] 0 0
Witten
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Germany
State/province [104] 0 0
Worms
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Germany
State/province [105] 0 0
Würzburg
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Germany
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Zweibrücken

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01500759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Erland Erdmann, Prof
Address 0 0
Klinikum der Universität zu Köln
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries