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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
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Secondary ID [1]
0
0
001
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Universal Trial Number (UTN)
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Trial acronym
SchlaHF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure
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0
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Left Ventricular Systolic Dysfunction
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0
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Condition category
Condition code
Respiratory
0
0
0
0
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Sleep apnoea
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Cardiovascular
0
0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of SDB in Chronic HF Patients
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Assessment method [1]
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SDB= Sleep disordered breathing; HF= Heart failure
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Timepoint [1]
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1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility
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Secondary outcome [1]
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0
Left Ventricular Ejection Fraction
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Assessment method [1]
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0
Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole
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Timepoint [1]
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0
1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution
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Secondary outcome [2]
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0
Age
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Assessment method [2]
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0
Age years
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Timepoint [2]
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1-time single assessment at baseline
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Secondary outcome [3]
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0
Body Mass Index
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Assessment method [3]
0
0
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Timepoint [3]
0
0
1-time single assessment at baseline
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Secondary outcome [4]
0
0
Male Gender
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Assessment method [4]
0
0
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Timepoint [4]
0
0
1-time single assessment at baseline
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Secondary outcome [5]
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0
NYHA Class =III
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Assessment method [5]
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0
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.
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Timepoint [5]
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At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records
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Secondary outcome [6]
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0
Ischemic Etiology
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Assessment method [6]
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0
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.
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Timepoint [6]
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1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.
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Secondary outcome [7]
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0
Atrial Fibrillation
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Assessment method [7]
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0
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Timepoint [7]
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1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records
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Secondary outcome [8]
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0
Nocturnal Dyspnea
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Assessment method [8]
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0
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Timepoint [8]
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1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records
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Secondary outcome [9]
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0
Nocturia =3 Times/Night
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Assessment method [9]
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0
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Timepoint [9]
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1-time: At baseline nocturia was assessed 1 time (anamnesis)
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Secondary outcome [10]
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0
Apnoea-Hypopnea-Index
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Assessment method [10]
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0
Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep
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Timepoint [10]
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1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility
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Secondary outcome [11]
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0
Oxygen Desaturation Index
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Assessment method [11]
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0
Number of times that arterial blood oxygen saturation Drops by =3% from the Basic value.
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Timepoint [11]
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0
1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility
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Secondary outcome [12]
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0
Mean SpO2
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Assessment method [12]
0
0
Saturation of oxygen
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Timepoint [12]
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0
1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility
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Secondary outcome [13]
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0
Min SpO2
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Assessment method [13]
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0
Lowest Saturation with oxygen
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Timepoint [13]
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1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility
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Secondary outcome [14]
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0
Medication ACE Inhibitors and/ARBs
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Assessment method [14]
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0
ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
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Timepoint [14]
0
0
1-time: At baseline medication was assessed 1 time (anamnesis)
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Secondary outcome [15]
0
0
Beta-blocker
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Assessment method [15]
0
0
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Timepoint [15]
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0
1-time: At baseline medication was assessed 1 time (anamnesis)
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Secondary outcome [16]
0
0
Diuretics
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Assessment method [16]
0
0
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Timepoint [16]
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0
1-time: At baseline medication was assessed 1 time (anamnesis)
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Secondary outcome [17]
0
0
Digitalis
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Assessment method [17]
0
0
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Timepoint [17]
0
0
1-time: At baseline medication was assessed 1 time (anamnesis)
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Secondary outcome [18]
0
0
Aldosterone Antagonists
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Assessment method [18]
0
0
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Timepoint [18]
0
0
1-time: At baseline medication was assessed 1 time (anamnesis)
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Secondary outcome [19]
0
0
Male Gender as Predictor for SDB in Chronic HF
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Assessment method [19]
0
0
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
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Timepoint [19]
0
0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
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Secondary outcome [20]
0
0
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF
Query!
Assessment method [20]
0
0
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
Query!
Timepoint [20]
0
0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
Query!
Secondary outcome [21]
0
0
Ischemic Etiology as Predictor for SDB in Chronic HF
Query!
Assessment method [21]
0
0
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
Query!
Timepoint [21]
0
0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
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Secondary outcome [22]
0
0
NYHA Class >= III as Predictor for SDB in Chronic HF
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Assessment method [22]
0
0
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
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Timepoint [22]
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0
1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
6876
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
0
0
Westmead Hospital - Westmead
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Recruitment hospital [2]
0
0
Rivercity Private Hospital - Auchenflower
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Recruitment hospital [3]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
0
0
Melbourne Sleep Disorders Centre - East Melbourne
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Recruitment hospital [5]
0
0
Baker IDI Heart and Diabetes Institute - Melbourne
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Recruitment hospital [6]
0
0
St Vincents and Mercy Private Hospital - Melbourne
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Recruitment hospital [7]
0
0
Hollywood Private Hospital (CVS) - Nedlands
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Recruitment postcode(s) [1]
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0
2145 - Westmead
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Recruitment postcode(s) [2]
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0
4066 - Auchenflower
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Recruitment postcode(s) [3]
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0
5000 - Adelaide
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Recruitment postcode(s) [4]
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0
3002 - East Melbourne
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Recruitment postcode(s) [5]
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0
3004 - Melbourne
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Recruitment postcode(s) [6]
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0
3065 - Melbourne
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Recruitment postcode(s) [7]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
Germany
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State/province [1]
0
0
Rheinland-Pfalz
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Country [2]
0
0
Germany
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State/province [2]
0
0
Aachen
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Country [3]
0
0
Germany
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State/province [3]
0
0
Alzey
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Country [4]
0
0
Germany
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State/province [4]
0
0
Arnsberg
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Country [5]
0
0
Germany
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State/province [5]
0
0
Bad Berka
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Country [6]
0
0
Germany
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State/province [6]
0
0
Bad Krozingen
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Country [7]
0
0
Germany
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State/province [7]
0
0
Bad Mergentheim
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Country [8]
0
0
Germany
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State/province [8]
0
0
Bad Oeynhausen
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Country [9]
0
0
Germany
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State/province [9]
0
0
Bad Wurzach
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Country [10]
0
0
Germany
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State/province [10]
0
0
Bautzen
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Country [11]
0
0
Germany
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State/province [11]
0
0
Bergisch Gladbach
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Country [12]
0
0
Germany
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State/province [12]
0
0
Berlin
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Country [13]
0
0
Germany
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State/province [13]
0
0
Bernau
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Country [14]
0
0
Germany
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State/province [14]
0
0
Bielefeld
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Country [15]
0
0
Germany
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State/province [15]
0
0
Bochum
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Country [16]
0
0
Germany
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State/province [16]
0
0
Bonn
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Country [17]
0
0
Germany
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State/province [17]
0
0
Bottrop
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Country [18]
0
0
Germany
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State/province [18]
0
0
Brühl
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Country [19]
0
0
Germany
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State/province [19]
0
0
Burg/Spreewald
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Country [20]
0
0
Germany
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State/province [20]
0
0
Castrop-Rauxel
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Country [21]
0
0
Germany
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State/province [21]
0
0
Chemnitz
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Country [22]
0
0
Germany
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State/province [22]
0
0
Coburg
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Country [23]
0
0
Germany
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State/province [23]
0
0
Coswig
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Country [24]
0
0
Germany
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State/province [24]
0
0
Cottbus
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Country [25]
0
0
Germany
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State/province [25]
0
0
Dortmund
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Country [26]
0
0
Germany
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State/province [26]
0
0
Dresden
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Country [27]
0
0
Germany
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State/province [27]
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0
Duesseldorf
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Country [28]
0
0
Germany
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State/province [28]
0
0
Düsseldorf
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Country [29]
0
0
Germany
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State/province [29]
0
0
Emmendingen
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Country [30]
0
0
Germany
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State/province [30]
0
0
Erfurt
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Country [31]
0
0
Germany
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State/province [31]
0
0
Erlangen
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Country [32]
0
0
Germany
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State/province [32]
0
0
Essen
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Country [33]
0
0
Germany
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State/province [33]
0
0
Flonheim
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Country [34]
0
0
Germany
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State/province [34]
0
0
Forst
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Country [35]
0
0
Germany
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State/province [35]
0
0
Frankfurt
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Country [36]
0
0
Germany
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State/province [36]
0
0
Frechen
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Country [37]
0
0
Germany
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State/province [37]
0
0
Freiburg im Breisgau
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Country [38]
0
0
Germany
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State/province [38]
0
0
Gladbeck
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Country [39]
0
0
Germany
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State/province [39]
0
0
Günzburg
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Country [40]
0
0
Germany
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State/province [40]
0
0
Gütersloh
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Country [41]
0
0
Germany
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State/province [41]
0
0
Hagen
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Country [42]
0
0
Germany
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State/province [42]
0
0
Hamburg
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Country [43]
0
0
Germany
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State/province [43]
0
0
Hannover
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Country [44]
0
0
Germany
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State/province [44]
0
0
Heidelberg
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Country [45]
0
0
Germany
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State/province [45]
0
0
Herne
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Country [46]
0
0
Germany
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State/province [46]
0
0
Herten
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Country [47]
0
0
Germany
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State/province [47]
0
0
Hoyerswerda
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Country [48]
0
0
Germany
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State/province [48]
0
0
Karlstadt
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Country [49]
0
0
Germany
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State/province [49]
0
0
Kassel
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Country [50]
0
0
Germany
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State/province [50]
0
0
Kempen
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0
0
Germany
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0
0
Kitzingen
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0
0
Germany
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0
0
Krefeld
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0
0
Germany
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0
0
Köln
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0
0
Germany
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0
0
Königs Wusterhausen
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0
0
Germany
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0
0
Leipzig
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0
0
Germany
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0
0
Leisnig
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0
0
Germany
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0
0
Lengerich
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0
0
Germany
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0
0
Lindlar
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0
0
Germany
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0
0
Lingen
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0
0
Germany
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0
0
Ludwigsburg
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0
0
Germany
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0
0
Lübeck
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0
0
Germany
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0
0
Mainz
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Country [63]
0
0
Germany
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State/province [63]
0
0
Mannheim
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Country [64]
0
0
Germany
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State/province [64]
0
0
Marburg
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Country [65]
0
0
Germany
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State/province [65]
0
0
Meissen
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Country [66]
0
0
Germany
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State/province [66]
0
0
Memmingen
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Country [67]
0
0
Germany
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State/province [67]
0
0
Menden
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Country [68]
0
0
Germany
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State/province [68]
0
0
Metzingen
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Country [69]
0
0
Germany
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State/province [69]
0
0
Minden
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Country [70]
0
0
Germany
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State/province [70]
0
0
Moers
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Country [71]
0
0
Germany
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State/province [71]
0
0
Mühldorf
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Country [72]
0
0
Germany
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State/province [72]
0
0
Mülheim an der Ruhr
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Country [73]
0
0
Germany
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State/province [73]
0
0
München
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Country [74]
0
0
Germany
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State/province [74]
0
0
Münster
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Country [75]
0
0
Germany
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State/province [75]
0
0
Neuss
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Country [76]
0
0
Germany
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State/province [76]
0
0
Nienburg
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Country [77]
0
0
Germany
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State/province [77]
0
0
Nürnberg
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Country [78]
0
0
Germany
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State/province [78]
0
0
Ochtrup
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Country [79]
0
0
Germany
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State/province [79]
0
0
Plauen
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Country [80]
0
0
Germany
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State/province [80]
0
0
Radebeul
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Country [81]
0
0
Germany
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State/province [81]
0
0
Ratingen
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Country [82]
0
0
Germany
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State/province [82]
0
0
Ratzeburg
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Country [83]
0
0
Germany
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State/province [83]
0
0
Ravensburg
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Country [84]
0
0
Germany
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State/province [84]
0
0
Recklinghausen
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Country [85]
0
0
Germany
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State/province [85]
0
0
Regensburg
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Country [86]
0
0
Germany
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State/province [86]
0
0
Reinbek
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Country [87]
0
0
Germany
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State/province [87]
0
0
Remscheid
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Country [88]
0
0
Germany
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State/province [88]
0
0
Rheine
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Country [89]
0
0
Germany
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State/province [89]
0
0
Rinteln
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Country [90]
0
0
Germany
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State/province [90]
0
0
Schwerte
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Country [91]
0
0
Germany
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State/province [91]
0
0
Schönefeld
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Country [92]
0
0
Germany
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State/province [92]
0
0
Soest
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Country [93]
0
0
Germany
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State/province [93]
0
0
Sonneberg
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0
0
Germany
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State/province [94]
0
0
Stollberg
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Country [95]
0
0
Germany
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State/province [95]
0
0
Uelzen
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Country [96]
0
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Germany
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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
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Witten
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Germany
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Worms
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Germany
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Würzburg
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Germany
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Zweibrücken
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Funding & Sponsors
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Commercial sector/industry
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ResMed
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01500759
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Trial related presentations / publications
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 registry. BMC Cardiovasc Disord. 2014 Apr 9;14:46. doi: 10.1186/1471-2261-14-46. 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. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9. 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 Heart Assoc. 2017 Nov 29;6(12):e005899. doi: 10.1161/JAHA.116.005899.
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Public notes
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Contacts
Principal investigator
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Erland Erdmann, Prof
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Address
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Klinikum der Universität zu Köln
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Woehrle H, Oldenburg O, Arzt M, Graml A, Erdmann E...
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Journal
Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A,...
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Journal
Arzt M, Oldenburg O, Graml A, Erdmann E, Teschler ...
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Results are available at
https://clinicaltrials.gov/study/NCT01500759
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