Trial Outcomes & Findings for Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea. (NCT NCT02963597)
NCT ID: NCT02963597
Last Updated: 2020-03-30
Results Overview
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
48 hours
Results posted on
2020-03-30
Participant Flow
Subjects were recruited from the inpatient clinical services of the Albert Einstein Medical Center Philadelphia (US) and from the Heart and Diabetes Center of North Rhine-Westphalia (Germany). Patients signed an informed consent for the study prior to any study-related procedure. Before randomization, all eligibility criteria were confirmed.
Participant milestones
| Measure |
Group A
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.
Baseline characteristics by cohort
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provides non-invasive ventilatory support to treat patients with sleep-disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in the sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 9.96 • n=7 Participants
|
67.75 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Body mass index (BMI)
|
28.7 kg/m2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
31.2 kg/m2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
30.0 kg/m2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Type of heart failure according to EF (HFrEF/HFpEF)
HFpEF
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Type of heart failure according to EF (HFrEF/HFpEF)
HFrEF
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoking history
Active smoker
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Smoking history
Former smoker
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Smoking history
Never smoker
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of COPD
Diagnosis of COPD confirmed with PFTs
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
History of COPD
No diagnosis of COPD or negative PFTs
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Apnea-hypopnea index (AHI)
|
31.7 events/hour
STANDARD_DEVIATION 8 • n=5 Participants
|
34.3 events/hour
STANDARD_DEVIATION 9.2 • n=7 Participants
|
33.1 events/hour
STANDARD_DEVIATION 8.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Patients pulmonary artery systolic pressures were measured by transthoracic echocardiography (TTE) on admission and 48 hours after enrollment.
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Pulmonary Artery Systolic Pressure.
Baseline
|
58.6 mmHg
Interval 53.6 to 63.5
|
62.7 mmHg
Interval 56.2 to 69.2
|
|
Pulmonary Artery Systolic Pressure.
After 48 hours
|
42.8 mmHg
Interval 37.4 to 48.1
|
57.5 mmHg
Interval 49.9 to 65.1
|
SECONDARY outcome
Timeframe: 48 hours6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
Baseline
|
202.6 meters
Interval 151.5 to 253.6
|
153.6 meters
Interval 96.3 to 210.9
|
|
Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
After 48 hours
|
222.6 meters
Interval 156.9 to 288.2
|
161.8 meters
Interval 104.5 to 219.1
|
SECONDARY outcome
Timeframe: 48 hoursTo compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
Baseline
|
1087.6 picogram/mililiter
Interval 528.29 to 1646.9
|
1532.7 picogram/mililiter
Interval 735.5 to 2329.9
|
|
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
After 48 hours
|
466.5 picogram/mililiter
Interval 258.0 to 675.0
|
1500.2 picogram/mililiter
Interval 274.1 to 2726.2
|
SECONDARY outcome
Timeframe: 1 yearThe total stay in the hospital during the admission will be measured by days.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Length of Stay
|
9.2 days
Interval 5.3 to 13.0
|
13.7 days
Interval 2.2 to 25.2
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data was not available for all participants.
Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Blood Oxygenation.
Baseline
|
72.84 mmHg
Interval 59.5 to 86.1
|
76.7 mmHg
Interval 69.9 to 83.5
|
|
Blood Oxygenation.
After 48 hours
|
80 mmHg
Interval 64.5 to 95.5
|
77.9 mmHg
Interval 71.2 to 84.5
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data was not available for participants after 48 hours. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point
Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes. Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Heart Failure Symptoms
Baseline
|
3.2 units on a scale
Interval 2.9 to 3.4
|
3.5 units on a scale
Interval 3.2 to 3.8
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data after 48 hours was not available for the participants of the study. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point
Change in fluid retention as measured by weight at baseline and after 48 hours.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Fluid Retention
Baseline
|
82.6 Kg
Interval 70.3 to 94.9
|
94.7 Kg
Interval 81.6 to 107.8
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data was not available for all the subjects at baseline and 48 hours after. PI has left the institution; efforts to contact unsuccessful; clarifying data information not available
Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=11 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
E/e' as an Assumption of LVEDP.
Baseline
|
18.6 Ratio
Interval 14.5 to 22.5
|
18.2 Ratio
Interval 13.6 to 22.7
|
|
E/e' as an Assumption of LVEDP.
After 48 hours
|
14.8 Ratio
Interval 11.2 to 18.3
|
16.5 Ratio
Interval 13.9 to 19.0
|
POST_HOC outcome
Timeframe: 48 hoursPopulation: Analyzing only patients with heart failure with reduced ejection fraction (\<45%).
Calculated ejection fraction in patients with heart failure with reduced ejection fraction (\<45%) at baseline and after 48 hours.
Outcome measures
| Measure |
Group A
n=10 Participants
Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.
AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
Group B
n=10 Participants
Standard medical therapy only.
Standard Medical Therapy: Standard medical therapy according to current guidelines.
|
|---|---|---|
|
Ejection Fraction in HFrEF
Baseline
|
23 percentage (%)
Interval 17.12 to 28.88
|
26.8 percentage (%)
Interval 18.4 to 35.3
|
|
Ejection Fraction in HFrEF
After 48 hours
|
30 percentage (%)
Interval 26.6 to 32.9
|
26.7 percentage (%)
Interval 18.3 to 35.2
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place