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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01500759




Registration number
NCT01500759
Ethics application status
Date submitted
23/12/2011
Date registered
28/12/2011
Date last updated
9/07/2020

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
Respiratory 0 0 0 0
Sleep apnoea
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular 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
Primary outcome [1] 0 0
Prevalence of SDB in Chronic HF Patients
Timepoint [1] 0 0
1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility
Secondary outcome [1] 0 0
Left Ventricular Ejection Fraction
Timepoint [1] 0 0
1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution
Secondary outcome [2] 0 0
Age
Timepoint [2] 0 0
1-time single assessment at baseline
Secondary outcome [3] 0 0
Body Mass Index
Timepoint [3] 0 0
1-time single assessment at baseline
Secondary outcome [4] 0 0
Male Gender
Timepoint [4] 0 0
1-time single assessment at baseline
Secondary outcome [5] 0 0
NYHA Class =III
Timepoint [5] 0 0
At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records
Secondary outcome [6] 0 0
Ischemic Etiology
Timepoint [6] 0 0
1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.
Secondary outcome [7] 0 0
Atrial Fibrillation
Timepoint [7] 0 0
1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records
Secondary outcome [8] 0 0
Nocturnal Dyspnea
Timepoint [8] 0 0
1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
Secondary outcome [9] 0 0
Nocturia =3 Times/Night
Timepoint [9] 0 0
1-time: At baseline nocturia was assessed 1 time (anamnesis)
Secondary outcome [10] 0 0
Apnoea-Hypopnea-Index
Timepoint [10] 0 0
1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility
Secondary outcome [11] 0 0
Oxygen Desaturation Index
Timepoint [11] 0 0
1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility
Secondary outcome [12] 0 0
Mean SpO2
Timepoint [12] 0 0
1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility
Secondary outcome [13] 0 0
Min SpO2
Timepoint [13] 0 0
1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility
Secondary outcome [14] 0 0
Medication ACE Inhibitors and/ARBs
Timepoint [14] 0 0
1-time: At baseline medication was assessed 1 time (anamnesis)
Secondary outcome [15] 0 0
Beta-blocker
Timepoint [15] 0 0
1-time: At baseline medication was assessed 1 time (anamnesis)
Secondary outcome [16] 0 0
Diuretics
Timepoint [16] 0 0
1-time: At baseline medication was assessed 1 time (anamnesis)
Secondary outcome [17] 0 0
Digitalis
Timepoint [17] 0 0
1-time: At baseline medication was assessed 1 time (anamnesis)
Secondary outcome [18] 0 0
Aldosterone Antagonists
Timepoint [18] 0 0
1-time: At baseline medication was assessed 1 time (anamnesis)
Secondary outcome [19] 0 0
Male Gender as Predictor for SDB in Chronic HF
Timepoint [19] 0 0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Secondary outcome [20] 0 0
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF
Timepoint [20] 0 0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Secondary outcome [21] 0 0
Ischemic Etiology as Predictor for SDB in Chronic HF
Timepoint [21] 0 0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Secondary outcome [22] 0 0
NYHA Class >= III as Predictor for SDB in Chronic HF
Timepoint [22] 0 0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

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
Sex
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
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
6876
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
Rheinland-Pfalz
Country [2] 0 0
Germany
State/province [2] 0 0
Aachen
Country [3] 0 0
Germany
State/province [3] 0 0
Alzey
Country [4] 0 0
Germany
State/province [4] 0 0
Arnsberg
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Berka
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Krozingen
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Mergentheim
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Oeynhausen
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Wurzach
Country [10] 0 0
Germany
State/province [10] 0 0
Bautzen
Country [11] 0 0
Germany
State/province [11] 0 0
Bergisch Gladbach
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bernau
Country [14] 0 0
Germany
State/province [14] 0 0
Bielefeld
Country [15] 0 0
Germany
State/province [15] 0 0
Bochum
Country [16] 0 0
Germany
State/province [16] 0 0
Bonn
Country [17] 0 0
Germany
State/province [17] 0 0
Bottrop
Country [18] 0 0
Germany
State/province [18] 0 0
Brühl
Country [19] 0 0
Germany
State/province [19] 0 0
Burg/Spreewald
Country [20] 0 0
Germany
State/province [20] 0 0
Castrop-Rauxel
Country [21] 0 0
Germany
State/province [21] 0 0
Chemnitz
Country [22] 0 0
Germany
State/province [22] 0 0
Coburg
Country [23] 0 0
Germany
State/province [23] 0 0
Coswig
Country [24] 0 0
Germany
State/province [24] 0 0
Cottbus
Country [25] 0 0
Germany
State/province [25] 0 0
Dortmund
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Duesseldorf
Country [28] 0 0
Germany
State/province [28] 0 0
Düsseldorf
Country [29] 0 0
Germany
State/province [29] 0 0
Emmendingen
Country [30] 0 0
Germany
State/province [30] 0 0
Erfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Flonheim
Country [34] 0 0
Germany
State/province [34] 0 0
Forst
Country [35] 0 0
Germany
State/province [35] 0 0
Frankfurt
Country [36] 0 0
Germany
State/province [36] 0 0
Frechen
Country [37] 0 0
Germany
State/province [37] 0 0
Freiburg im Breisgau
Country [38] 0 0
Germany
State/province [38] 0 0
Gladbeck
Country [39] 0 0
Germany
State/province [39] 0 0
Günzburg
Country [40] 0 0
Germany
State/province [40] 0 0
Gütersloh
Country [41] 0 0
Germany
State/province [41] 0 0
Hagen
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Hannover
Country [44] 0 0
Germany
State/province [44] 0 0
Heidelberg
Country [45] 0 0
Germany
State/province [45] 0 0
Herne
Country [46] 0 0
Germany
State/province [46] 0 0
Herten
Country [47] 0 0
Germany
State/province [47] 0 0
Hoyerswerda
Country [48] 0 0
Germany
State/province [48] 0 0
Karlstadt
Country [49] 0 0
Germany
State/province [49] 0 0
Kassel
Country [50] 0 0
Germany
State/province [50] 0 0
Kempen
Country [51] 0 0
Germany
State/province [51] 0 0
Kitzingen
Country [52] 0 0
Germany
State/province [52] 0 0
Krefeld
Country [53] 0 0
Germany
State/province [53] 0 0
Köln
Country [54] 0 0
Germany
State/province [54] 0 0
Königs Wusterhausen
Country [55] 0 0
Germany
State/province [55] 0 0
Leipzig
Country [56] 0 0
Germany
State/province [56] 0 0
Leisnig
Country [57] 0 0
Germany
State/province [57] 0 0
Lengerich
Country [58] 0 0
Germany
State/province [58] 0 0
Lindlar
Country [59] 0 0
Germany
State/province [59] 0 0
Lingen
Country [60] 0 0
Germany
State/province [60] 0 0
Ludwigsburg
Country [61] 0 0
Germany
State/province [61] 0 0
Lübeck
Country [62] 0 0
Germany
State/province [62] 0 0
Mainz
Country [63] 0 0
Germany
State/province [63] 0 0
Mannheim
Country [64] 0 0
Germany
State/province [64] 0 0
Marburg
Country [65] 0 0
Germany
State/province [65] 0 0
Meissen
Country [66] 0 0
Germany
State/province [66] 0 0
Memmingen
Country [67] 0 0
Germany
State/province [67] 0 0
Menden
Country [68] 0 0
Germany
State/province [68] 0 0
Metzingen
Country [69] 0 0
Germany
State/province [69] 0 0
Minden
Country [70] 0 0
Germany
State/province [70] 0 0
Moers
Country [71] 0 0
Germany
State/province [71] 0 0
Mühldorf
Country [72] 0 0
Germany
State/province [72] 0 0
Mülheim an der Ruhr
Country [73] 0 0
Germany
State/province [73] 0 0
München
Country [74] 0 0
Germany
State/province [74] 0 0
Münster
Country [75] 0 0
Germany
State/province [75] 0 0
Neuss
Country [76] 0 0
Germany
State/province [76] 0 0
Nienburg
Country [77] 0 0
Germany
State/province [77] 0 0
Nürnberg
Country [78] 0 0
Germany
State/province [78] 0 0
Ochtrup
Country [79] 0 0
Germany
State/province [79] 0 0
Plauen
Country [80] 0 0
Germany
State/province [80] 0 0
Radebeul
Country [81] 0 0
Germany
State/province [81] 0 0
Ratingen
Country [82] 0 0
Germany
State/province [82] 0 0
Ratzeburg
Country [83] 0 0
Germany
State/province [83] 0 0
Ravensburg
Country [84] 0 0
Germany
State/province [84] 0 0
Recklinghausen
Country [85] 0 0
Germany
State/province [85] 0 0
Regensburg
Country [86] 0 0
Germany
State/province [86] 0 0
Reinbek
Country [87] 0 0
Germany
State/province [87] 0 0
Remscheid
Country [88] 0 0
Germany
State/province [88] 0 0
Rheine
Country [89] 0 0
Germany
State/province [89] 0 0
Rinteln
Country [90] 0 0
Germany
State/province [90] 0 0
Schwerte
Country [91] 0 0
Germany
State/province [91] 0 0
Schönefeld
Country [92] 0 0
Germany
State/province [92] 0 0
Soest
Country [93] 0 0
Germany
State/province [93] 0 0
Sonneberg
Country [94] 0 0
Germany
State/province [94] 0 0
Stollberg
Country [95] 0 0
Germany
State/province [95] 0 0
Uelzen
Country [96] 0 0
Germany
State/province [96] 0 0
Ulm
Country [97] 0 0
Germany
State/province [97] 0 0
Unna
Country [98] 0 0
Germany
State/province [98] 0 0
Viersen
Country [99] 0 0
Germany
State/province [99] 0 0
Waldkraiburg
Country [100] 0 0
Germany
State/province [100] 0 0
Wangen
Country [101] 0 0
Germany
State/province [101] 0 0
Weißenhorn
Country [102] 0 0
Germany
State/province [102] 0 0
Wiesbaden
Country [103] 0 0
Germany
State/province [103] 0 0
Witten
Country [104] 0 0
Germany
State/province [104] 0 0
Worms
Country [105] 0 0
Germany
State/province [105] 0 0
Würzburg
Country [106] 0 0
Germany
State/province [106] 0 0
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01500759