Trial Outcomes & Findings for Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure (NCT NCT00733343)
NCT ID: NCT00733343
Last Updated: 2020-05-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1325 participants
Primary outcome timeframe
time to first event, assessed for up to 70 weeks
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
Treatment Group
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC-american college of cardiology/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
Control Group
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
|---|---|---|
|
Overall Study
STARTED
|
666
|
659
|
|
Overall Study
COMPLETED
|
583
|
578
|
|
Overall Study
NOT COMPLETED
|
83
|
81
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Total
n=1325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 9.5 • n=666 Participants
|
69.3 years
STANDARD_DEVIATION 10.4 • n=659 Participants
|
69.5 years
STANDARD_DEVIATION 9.9 • n=1325 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=666 Participants
|
60 Participants
n=659 Participants
|
127 Participants
n=1325 Participants
|
|
Sex: Female, Male
Male
|
599 Participants
n=666 Participants
|
599 Participants
n=659 Participants
|
1198 Participants
n=1325 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Czechia
|
3 Participants
n=666 Participants
|
4 Participants
n=659 Participants
|
7 Participants
n=1325 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=666 Participants
|
1 Participants
n=659 Participants
|
1 Participants
n=1325 Participants
|
|
Region of Enrollment
Sweden
|
20 Participants
n=666 Participants
|
19 Participants
n=659 Participants
|
39 Participants
n=1325 Participants
|
|
Region of Enrollment
Norway
|
5 Participants
n=666 Participants
|
5 Participants
n=659 Participants
|
10 Participants
n=1325 Participants
|
|
Region of Enrollment
Finland
|
4 Participants
n=666 Participants
|
3 Participants
n=659 Participants
|
7 Participants
n=1325 Participants
|
|
Region of Enrollment
Denmark
|
12 Participants
n=666 Participants
|
12 Participants
n=659 Participants
|
24 Participants
n=1325 Participants
|
|
Region of Enrollment
United Kingdom
|
18 Participants
n=666 Participants
|
19 Participants
n=659 Participants
|
37 Participants
n=1325 Participants
|
|
Region of Enrollment
Australia
|
16 Participants
n=666 Participants
|
13 Participants
n=659 Participants
|
29 Participants
n=1325 Participants
|
|
Region of Enrollment
France
|
119 Participants
n=666 Participants
|
123 Participants
n=659 Participants
|
242 Participants
n=1325 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=666 Participants
|
1 Participants
n=659 Participants
|
3 Participants
n=1325 Participants
|
|
Region of Enrollment
Germany
|
467 Participants
n=666 Participants
|
459 Participants
n=659 Participants
|
926 Participants
n=1325 Participants
|
|
NYHA class
NYHA II
|
195 Participants
n=666 Participants
|
194 Participants
n=659 Participants
|
389 Participants
n=1325 Participants
|
|
NYHA class
NYHA III
|
456 Participants
n=666 Participants
|
454 Participants
n=659 Participants
|
910 Participants
n=1325 Participants
|
|
NYHA class
NYHA IV
|
11 Participants
n=666 Participants
|
6 Participants
n=659 Participants
|
17 Participants
n=1325 Participants
|
|
NYHA class
not assessed
|
4 Participants
n=666 Participants
|
5 Participants
n=659 Participants
|
9 Participants
n=1325 Participants
|
|
Diabetes
|
254 Participants
n=666 Participants
|
252 Participants
n=659 Participants
|
506 Participants
n=1325 Participants
|
|
Cause of Heart Failure
ischemic
|
390 Participants
n=666 Participants
|
366 Participants
n=659 Participants
|
756 Participants
n=1325 Participants
|
|
Cause of Heart Failure
nonischemic
|
263 Participants
n=666 Participants
|
276 Participants
n=659 Participants
|
539 Participants
n=1325 Participants
|
|
Cause of Heart Failure
not assessed
|
13 Participants
n=666 Participants
|
17 Participants
n=659 Participants
|
30 Participants
n=1325 Participants
|
|
Electrocardiographic Finding
sinus rhythm
|
372 Participants
n=666 Participants
|
395 Participants
n=659 Participants
|
767 Participants
n=1325 Participants
|
|
Electrocardiographic Finding
atrial fibrillation
|
178 Participants
n=666 Participants
|
147 Participants
n=659 Participants
|
325 Participants
n=1325 Participants
|
|
Electrocardiographic Finding
other
|
100 Participants
n=666 Participants
|
104 Participants
n=659 Participants
|
204 Participants
n=1325 Participants
|
|
Electrocardiographic Finding
not assessed
|
16 Participants
n=666 Participants
|
13 Participants
n=659 Participants
|
29 Participants
n=1325 Participants
|
|
Implanted device
no device
|
304 Participants
n=666 Participants
|
295 Participants
n=659 Participants
|
599 Participants
n=1325 Participants
|
|
Implanted device
non-CRT(cardiacresynchronisation therapy)pacemaker
|
32 Participants
n=666 Participants
|
29 Participants
n=659 Participants
|
61 Participants
n=1325 Participants
|
|
Implanted device
ICD (implantable cardioverter defibrillator)
|
163 Participants
n=666 Participants
|
161 Participants
n=659 Participants
|
324 Participants
n=1325 Participants
|
|
Implanted device
CRT-P
|
14 Participants
n=666 Participants
|
21 Participants
n=659 Participants
|
35 Participants
n=1325 Participants
|
|
Implanted device
CRT-D
|
153 Participants
n=666 Participants
|
153 Participants
n=659 Participants
|
306 Participants
n=1325 Participants
|
|
Concomitant cardiac medication
ACE inhibitor or ARB(AT1 recept blocker)
|
613 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
603 Participants
n=659 Participants • The values count the number of patients who have taken the respective medication.
|
1216 Participants
n=1325 Participants • The values count the number of patients who have taken the respective medication.
|
|
Concomitant cardiac medication
beta-blocker
|
612 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
611 Participants
n=659 Participants • The values count the number of patients who have taken the respective medication.
|
1223 Participants
n=1325 Participants • The values count the number of patients who have taken the respective medication.
|
|
Concomitant cardiac medication
aldosterone antagonist
|
316 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
325 Participants
n=659 Participants • The values count the number of patients who have taken the respective medication.
|
641 Participants
n=1325 Participants • The values count the number of patients who have taken the respective medication.
|
|
Concomitant cardiac medication
diuretic
|
561 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
561 Participants
n=659 Participants • The values count the number of patients who have taken the respective medication.
|
1122 Participants
n=1325 Participants • The values count the number of patients who have taken the respective medication.
|
|
Concomitant cardiac medication
cardiac glycoside
|
149 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
124 Participants
n=657 Participants • The values count the number of patients who have taken the respective medication.
|
273 Participants
n=1323 Participants • The values count the number of patients who have taken the respective medication.
|
|
Concomitant cardiac medication
antiarrhythmic drug
|
128 Participants
n=666 Participants • The values count the number of patients who have taken the respective medication.
|
89 Participants
n=659 Participants • The values count the number of patients who have taken the respective medication.
|
217 Participants
n=1325 Participants • The values count the number of patients who have taken the respective medication.
|
PRIMARY outcome
Timeframe: time to first event, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
|
335 Participants
|
360 Participants
|
PRIMARY outcome
Timeframe: time to first event, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
|
317 Participants
|
345 Participants
|
PRIMARY outcome
Timeframe: time to first event, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation
|
465 Participants
|
482 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Death From Any Cause
|
193 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Non-cardiovascular Death
|
35 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Cardiovascular Death
|
158 Participants
|
199 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
|
272 Participants
|
287 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
|
448 Participants
|
452 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
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
|
65 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
|
19 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 x at BaselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Age Baseline
|
69.3 years
Standard Deviation 10.4
|
69.6 years
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Body Weight Baseline
|
86.1 kg
Standard Deviation 17.5
|
85.6 kg
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 1 x baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Body Mass Index (BMI) Baseline
|
28.6 kg/cm2
Standard Deviation 5.1
|
28.4 kg/cm2
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 1x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Left Ventricular Ejection Fraction at Baseline
|
32.5 %total vol ventricle
Standard Deviation 8.0
|
32.2 %total vol ventricle
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Blood Pressure Systolic Baseline
|
122.1 mm Hg
Standard Deviation 19.6
|
122.3 mm Hg
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Blood Pressure Diastolic Baseline
|
73.3 mm Hg
Standard Deviation 11.5
|
73.7 mm Hg
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Hemoglobine Baseline
|
13.9 g/dl
Standard Deviation 1.5
|
13.8 g/dl
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Creatinine Baseline
|
1.4 mg/dl
Standard Deviation 0.6
|
1.4 mg/dl
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Glomerular Filtration Rate Baseline
|
59.3 ml/min/1.73m2
Standard Deviation 20.8
|
57.8 ml/min/1.73m2
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
6-Min Walk Distance
|
337.9 m
Standard Deviation 127.5
|
334.0 m
Standard Deviation 126.4
|
SECONDARY outcome
Timeframe: 1 x at baselineMeasure 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
Outcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
|
7.1 total score ESS
Standard Deviation 4.6
|
7.0 total score ESS
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 1 x at baselineMeasure 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.
Outcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Apnoea-Hypopnea-Index (AHI) at Baseline
|
31.7 events/hour
Standard Deviation 13.2
|
31.2 events/hour
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 1 x at baselineMeasure 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.
Outcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Central Apnoea Index/Total AHI
|
46.5 %central/totalapnea
Standard Deviation 30.0
|
44.6 %central/totalapnea
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Central AHI/Total AHI at Baseline
|
81.8 Central/totalAHI%
Standard Deviation 15.7
|
80.8 Central/totalAHI%
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 1 x at baselineNumber of oxygen desaturations per hour at baseline
Outcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Oxygen Desaturation Index (ODI) at Baseline
|
32.8 events/hour
Standard Deviation 19.0
|
32.1 events/hour
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Oxygen Saturation Baseline
|
92.8 %total hemoglobine
Standard Deviation 2.5
|
92.8 %total hemoglobine
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 1 x at baselineOutcome measures
| Measure |
Control Group
n=659 Participants
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
Treatment Group
n=666 Participants
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
|---|---|---|
|
Time With Oxygen Saturation Below 90%
|
55.7 min
Standard Deviation 73.9
|
50.5 min
Standard Deviation 68.2
|
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: the last follow up or at the last available observation within FU, assessed for up to 70 weeksPopulation: Data have not been collected
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group
Serious events: 482 serious events
Other events: 0 other events
Deaths: 232 deaths
Control Group
Serious events: 465 serious events
Other events: 0 other events
Deaths: 193 deaths
Serious adverse events
| Measure |
Treatment Group
n=666 participants at risk
treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
Europe: AutoSet CS (USA: VPAP Adapt SV): At least 3 hours average daily usage time
|
Control Group
n=659 participants at risk
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
|
|---|---|---|
|
Cardiac disorders
Cardiovascular death
|
29.9%
199/666 • Number of events 199
|
24.0%
158/659 • Number of events 158
|
|
General disorders
Primary end point
|
54.1%
360/666 • Number of events 360
|
50.8%
335/659 • Number of events 335
|
|
Cardiac disorders
Firt secondary endpoint
|
51.8%
345/666 • Number of events 345
|
48.1%
317/659 • Number of events 317
|
|
General disorders
Second secondary endpoint
|
72.4%
482/666 • Number of events 482
|
70.6%
465/659 • Number of events 465
|
|
General disorders
Hospitalization for any cause
|
67.9%
452/666 • Number of events 452
|
68.0%
448/659 • Number of events 448
|
|
Cardiac disorders
Unplanned hospitalization for worsening heart failure
|
43.1%
287/666 • Number of events 287
|
41.3%
272/659 • Number of events 272
|
|
Cardiac disorders
Heart transplantation
|
1.2%
8/666 • Number of events 8
|
1.8%
12/659 • Number of events 12
|
|
Cardiac disorders
Implantation of long-term VentricularAssistDev
|
2.4%
16/666 • Number of events 16
|
1.5%
10/659 • Number of events 10
|
|
General disorders
Resuscitation
|
3.8%
25/666 • Number of events 25
|
2.9%
19/659 • Number of events 19
|
|
Cardiac disorders
Resuscitation for cardiac arrest
|
2.7%
18/666 • Number of events 18
|
2.4%
16/659 • Number of events 16
|
|
Cardiac disorders
Appropriate Shock for ventricular arrhythmia
|
6.8%
45/666 • Number of events 45
|
9.9%
65/659 • Number of events 65
|
|
General disorders
Noncardiovascular death
|
5.0%
33/666 • Number of events 33
|
5.3%
35/659 • Number of events 35
|
Other adverse events
Adverse event data not reported
Additional Information
Martin R. Cowie, MD
Department of Cardiology, Imperial College London, Dovehouse St., London SW3 6LY, United Kingdom
Phone: +44 (0)20 7589 0
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place