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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00733343
Registration number
NCT00733343
Ethics application status
Date submitted
14/02/2008
Date registered
13/08/2008
Date last updated
12/05/2020
Titles & IDs
Public title
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
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Scientific title
Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
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Secondary ID [1]
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0
ISRCTN19572887
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Secondary ID [2]
0
0
01
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Universal Trial Number (UTN)
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Trial acronym
Serve-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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0
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Sleep Disordered Breathing
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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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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Europe: AutoSet CS (USA: VPAP Adapt SV)
Active comparator: Treatment Group - treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP (Variable Positive Airway Pressure) Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
No intervention: Control Group - standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Treatment: Devices: Europe: AutoSet CS (USA: VPAP Adapt SV)
At least 3 hours average daily usage time
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Intervention code [1]
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Treatment: Devices
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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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All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
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Assessment method [1]
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0
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Timepoint [1]
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0
time to first event, assessed for up to 70 weeks
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Primary outcome [2]
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0
Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
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Assessment method [2]
0
0
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Timepoint [2]
0
0
time to first event, assessed for up to 70 weeks
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Primary outcome [3]
0
0
All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation
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Assessment method [3]
0
0
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Timepoint [3]
0
0
time to first event, assessed for up to 70 weeks
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Secondary outcome [1]
0
0
Death From Any Cause
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Assessment method [1]
0
0
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Timepoint [1]
0
0
the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks
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Secondary outcome [2]
0
0
Non-cardiovascular Death
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Assessment method [2]
0
0
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Timepoint [2]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [3]
0
0
Cardiovascular Death
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Assessment method [3]
0
0
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Timepoint [3]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [4]
0
0
Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
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Assessment method [4]
0
0
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Timepoint [4]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [5]
0
0
Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
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Assessment method [5]
0
0
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Timepoint [5]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [6]
0
0
Adequate Shock in Patients With ICD (Evaluation of Appropriateness Will Also be Made by the Endpoint Review Committee, ERC), Long-Term Atrial Defibrillator Insertion or Cardiovascular Death
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Assessment method [6]
0
0
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Timepoint [6]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [7]
0
0
First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
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Assessment method [7]
0
0
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Timepoint [7]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [8]
0
0
First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
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Assessment method [8]
0
0
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Timepoint [8]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [9]
0
0
Age Baseline
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Assessment method [9]
0
0
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Timepoint [9]
0
0
1 x at Baseline
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Secondary outcome [10]
0
0
Body Weight Baseline
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Assessment method [10]
0
0
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Timepoint [10]
0
0
1 x at baseline
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Secondary outcome [11]
0
0
Body Mass Index (BMI) Baseline
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Assessment method [11]
0
0
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Timepoint [11]
0
0
1 x baseline
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Secondary outcome [12]
0
0
Left Ventricular Ejection Fraction at Baseline
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Assessment method [12]
0
0
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Timepoint [12]
0
0
1x at baseline
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Secondary outcome [13]
0
0
Blood Pressure Systolic Baseline
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Assessment method [13]
0
0
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Timepoint [13]
0
0
1 x at baseline
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Secondary outcome [14]
0
0
Blood Pressure Diastolic Baseline
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Assessment method [14]
0
0
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Timepoint [14]
0
0
1 x at baseline
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Secondary outcome [15]
0
0
Hemoglobine Baseline
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Assessment method [15]
0
0
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Timepoint [15]
0
0
1 x at baseline
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Secondary outcome [16]
0
0
Creatinine Baseline
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Assessment method [16]
0
0
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Timepoint [16]
0
0
1 x at baseline
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Secondary outcome [17]
0
0
Glomerular Filtration Rate Baseline
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Assessment method [17]
0
0
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Timepoint [17]
0
0
1 x at baseline
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Secondary outcome [18]
0
0
6-Min Walk Distance
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Assessment method [18]
0
0
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Timepoint [18]
0
0
1 x at baseline
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Secondary outcome [19]
0
0
Epworth Sleepiness Scale (ESS)
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Assessment method [19]
0
0
Measure Description: ESS is a self-administered questionnaire. It contains 8 questions. Questions are rated on a 4-point Likert scale (0-3); 0= would never doze, 3=high Chance of dozing. Range of scores 0-24. Global score= sum of all item scores. Copyright (c)MW Johns
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Timepoint [19]
0
0
1 x at baseline
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Secondary outcome [20]
0
0
Apnoea-Hypopnea-Index (AHI) at Baseline
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Assessment method [20]
0
0
Measure Description: The AHI is an index to describe the severity of Sleep Apnea. Apnea is cessation of breathing during sleep. Hypopnea is diminished breathing during sleep. The number of Apneas and Hypopneas are added up and divided by hours of sleep (Apneas + Hypopneas per hour). An AHI ranging from 5-15 describes mild Sleep Apnea. AHI 15-30 describes moderate Sleep Apnea. AHI \>30 describes severe Sleep Apnea.
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Timepoint [20]
0
0
1 x at baseline
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Secondary outcome [21]
0
0
Central Apnoea Index/Total AHI
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Assessment method [21]
0
0
Measure Description: Central apneas are partial or complete cessations of airflow caused by reduced or stopped neural Stimulation of the breathing muscles. For comparison: In obstructive apneas are caused by blocked airways that shut off the air although the breathing Stimulus is working.
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Timepoint [21]
0
0
1 x at baseline
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Secondary outcome [22]
0
0
Central AHI/Total AHI at Baseline
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Assessment method [22]
0
0
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Timepoint [22]
0
0
1 x at baseline
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Secondary outcome [23]
0
0
Oxygen Desaturation Index (ODI) at Baseline
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Assessment method [23]
0
0
Number of oxygen desaturations per hour at baseline
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Timepoint [23]
0
0
1 x at baseline
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Secondary outcome [24]
0
0
Oxygen Saturation Baseline
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Assessment method [24]
0
0
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Timepoint [24]
0
0
1 x at baseline
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Secondary outcome [25]
0
0
Time With Oxygen Saturation Below 90%
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Assessment method [25]
0
0
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Timepoint [25]
0
0
1 x at baseline
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Secondary outcome [26]
0
0
Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame
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Assessment method [26]
0
0
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Timepoint [26]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [27]
0
0
Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause
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Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [28]
0
0
Changes in NYHA Classification as Compared to Baseline
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Assessment method [28]
0
0
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Timepoint [28]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [29]
0
0
Changes in QoL (Minnesota) as Compared to Baseline
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Assessment method [29]
0
0
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Timepoint [29]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [30]
0
0
Changes in Renal Function (Based on Serum Creatinine) as Compared to Baseline
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Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [31]
0
0
Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline
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Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [32]
0
0
Changes of AHI and Oxygen Desaturation Index Compared to Baseline
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Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [33]
0
0
AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months
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Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [34]
0
0
Atrial Fibrillation at Follow-up Visits
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Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [35]
0
0
Number and Cost of Hospitalisations (With Tariff/DRG, Diagnoses and Procedures for Calculating DRG or Length of Stay and Level of Care Provided)
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Assessment method [35]
0
0
Query!
Timepoint [35]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [36]
0
0
Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm
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Assessment method [36]
0
0
Query!
Timepoint [36]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [37]
0
0
Difference in Cost of Resources Consumed
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Assessment method [37]
0
0
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Timepoint [37]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Query!
Secondary outcome [38]
0
0
Incremental Cost-efficacy Ratio
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Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Secondary outcome [39]
0
0
Incremental Cost-utility Ratio
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Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
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Eligibility
Key inclusion criteria
* Patients must be at least 22 years old
* Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
* 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 before randomisation
* 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
* No hospitalisation for heart failure for at least 4 weeks prior to inclusion
* Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) antagonists the reasons must be documented
* SDB (AHI > 15/h with = 50% central events and a central AHI = 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
* Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
* Patient is able to fully understand study information and signed informed consent
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Minimum age
22
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
* Significant COPD (chronic obstructive pulmonary disease) with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
* Oxygen saturation at rest during the day = 90% at inclusion
* Current use of Positive Airway Pressure (PAP) - therapy
* 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 prior to randomisation
* CRT (cardiac resynchronisation therapy)-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
* Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Acute myocarditis/pericarditis within 6 months prior to randomisation
* Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
* Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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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
1/02/2008
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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
1/06/2015
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Sample size
Target
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Accrual to date
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Final
1325
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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
St Vincents and Mercy Private Hospital - Melbourne
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Recruitment hospital [6]
0
0
Hollywood Private Hospital (CVS) - Nedlands
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Recruitment postcode(s) [1]
0
0
2145 - Westmead
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Recruitment postcode(s) [2]
0
0
4066 - Auchenflower
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Recruitment postcode(s) [3]
0
0
5000 - Adelaide
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Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
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Recruitment postcode(s) [5]
0
0
3065 - Melbourne
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Recruitment postcode(s) [6]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
Czechia
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State/province [1]
0
0
Brno
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Country [2]
0
0
Denmark
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State/province [2]
0
0
Copenhagen
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Country [3]
0
0
Denmark
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State/province [3]
0
0
Glostrup
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Country [4]
0
0
Denmark
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State/province [4]
0
0
Århus C
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Country [5]
0
0
Denmark
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State/province [5]
0
0
Århus N
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Country [6]
0
0
Finland
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State/province [6]
0
0
Helsinki
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Country [7]
0
0
Finland
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State/province [7]
0
0
Tampere
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Country [8]
0
0
France
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State/province [8]
0
0
Amneville
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Country [9]
0
0
France
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State/province [9]
0
0
Angers
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Country [10]
0
0
France
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State/province [10]
0
0
Antibes
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Country [11]
0
0
France
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State/province [11]
0
0
Antony
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Country [12]
0
0
France
Query!
State/province [12]
0
0
Belfort
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Country [13]
0
0
France
Query!
State/province [13]
0
0
Besancon
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Country [14]
0
0
France
Query!
State/province [14]
0
0
Beziers
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bordeaux
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Country [16]
0
0
France
Query!
State/province [16]
0
0
Caen Cedex
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Country [17]
0
0
France
Query!
State/province [17]
0
0
Cannes
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Creteil
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Country [19]
0
0
France
Query!
State/province [19]
0
0
Echirolles
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Forbach
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Country [21]
0
0
France
Query!
State/province [21]
0
0
Grenoble
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Country [22]
0
0
France
Query!
State/province [22]
0
0
Haguenau
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
L'Union
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Country [24]
0
0
France
Query!
State/province [24]
0
0
Lille
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Lyon
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Country [26]
0
0
France
Query!
State/province [26]
0
0
Metz
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Montbeliard
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Montpellier
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Montreuil
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Mulhouse
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Ollioules
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Paris
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Pessac
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Poitiers
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Pont-à-mousson
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Pontoise
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Rennes
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Rouen
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Saint Avold
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Country [40]
0
0
France
Query!
State/province [40]
0
0
Saint Louis
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Country [41]
0
0
France
Query!
State/province [41]
0
0
Saint- Etienne
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Country [42]
0
0
France
Query!
State/province [42]
0
0
St Dié des Vosges
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Country [43]
0
0
France
Query!
State/province [43]
0
0
Toulouse
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Country [44]
0
0
France
Query!
State/province [44]
0
0
Trouville
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Vandoeuvre les Nancy
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Verdun
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Rheinland-Pfalz
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Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Aachen
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Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Alzey
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Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Arnsberg
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Bad Berka
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Country [52]
0
0
Germany
Query!
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Essen
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Flonheim
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Forst
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Newcastle
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Taunton
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ResMed
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Other collaborator category [1]
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CRI-The Clinical Research Institute GmbH
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Ethics approval
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Summary
Brief summary
The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.
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Trial website
https://clinicaltrials.gov/study/NCT00733343
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Trial related presentations / publications
Cowie MR, Wegscheider K, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Heart Failure. N Engl J Med. 2016 Feb 18;374(7):690-1. doi: 10.1056/NEJMc1515007. No abstract available. Eulenburg C, Wegscheider K, Woehrle H, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Cowie MR. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modelling analysis. Lancet Respir Med. 2016 Nov;4(11):873-881. doi: 10.1016/S2213-2600(16)30244-2. Epub 2016 Aug 31. Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Wegscheider K. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017 Aug 31;50(2):1601692. doi: 10.1183/13993003.01692-2016. Print 2017 Aug. Shafazand S, Badr MS. Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure. J Clin Sleep Med. 2016 Jan;12(1):147-50. doi: 10.5664/jcsm.5420. No abstract available. Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.
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Public notes
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Contacts
Principal investigator
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Helmut Teschler, Prof.
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Universitätsklinikum Essen
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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
Cowie MR, Wegscheider K, Teschler H. Adaptive Serv...
[
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]
Journal
Eulenburg C, Wegscheider K, Woehrle H, Angermann C...
[
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Journal
Woehrle H, Cowie MR, Eulenburg C, Suling A, Angerm...
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Results are available at
https://clinicaltrials.gov/study/NCT00733343
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