Trial Outcomes & Findings for Cardiovascular Improvements With MV ASV Therapy in Heart Failure (NCT NCT01953874)
NCT ID: NCT01953874
Last Updated: 2018-02-28
Results Overview
A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.
TERMINATED
NA
126 participants
Baseline, 6 months
2018-02-28
Participant Flow
Participant milestones
| Measure |
MV ASV+OMT
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
61
|
|
Overall Study
COMPLETED
|
65
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
Baseline characteristics by cohort
| Measure |
MV ASV+OMT
n=65 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
43 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Body mass index
|
32.3 kg/m^2
STANDARD_DEVIATION 9.0 • n=5 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 8.6 • n=7 Participants
|
31.9 kg/m^2
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class I
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class II
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class III
|
32 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class IV
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Not done
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
Reduced ejection fraction (</=45%)
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
Preserved ejection fraction (>45%)
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Comorbid Conditions
Diabetes mellitus
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Comorbid Conditions
Hypertension
|
52 participants
n=5 Participants
|
56 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Comorbid Conditions
COPD
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Ischemic HF etiology
|
26 participants
n=5 Participants
|
18 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Atrial fibrillation
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Implanted device
Pacemaker
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Implanted device
ICD
|
26 participants
n=5 Participants
|
15 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
N-terminal pro-brain natriuretic peptide (NT pro-BNP)
|
3468.5 pg/mL
STANDARD_DEVIATION 4231.6 • n=5 Participants
|
6056.4 pg/mL
STANDARD_DEVIATION 8401.9 • n=7 Participants
|
4752.0 pg/mL
STANDARD_DEVIATION 6734.9 • n=5 Participants
|
|
6-minute walk distance
|
221.4 meters
STANDARD_DEVIATION 122.7 • n=5 Participants
|
196.1 meters
STANDARD_DEVIATION 114.6 • n=7 Participants
|
209.2 meters
STANDARD_DEVIATION 119 • n=5 Participants
|
|
Concomitant medications
ACE-I or ARB (HFrEF only)
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Concomitant medications
Beta blocker (HFrEF only)
|
47 participants
n=5 Participants
|
46 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Concomitant medications
Aldosterone agonist
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Concomitant medications
Loop diuretic
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsA rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.
Outcome measures
| Measure |
MV ASV+OMT
n=65 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Global Rank Endpoint
|
50.4 Standardized global rank order value
Standard Deviation 28.3
|
49.6 Standardized global rank order value
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Reasons 6MWT was not performed: In the MV ASV+OMT arm, 5 were discontinued prematurely, 3 participants could not walk, 4 participants were too critically ill, and 2 participants refused. In the OMT only arm, 12 were discontinued prematurely, 1 participant could not walk, and 2 participants refused.
Change in functional parameters as measured by 6-minute walk test (6MWT)
Outcome measures
| Measure |
MV ASV+OMT
n=51 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=46 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Six-minute Walk Distance
|
22.6 meters
Standard Deviation 131.3
|
61.2 meters
Standard Deviation 117.4
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.
Outcome measures
| Measure |
MV ASV+OMT
n=41 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=44 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
NT Pro-BNP
|
172.7 pg/mL
Standard Deviation 3429.1
|
-1069.9 pg/mL
Standard Deviation 6768.2
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
MV ASV+OMT
n=52 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=49 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
|
20.3 scores on a scale
Standard Deviation 28.3
|
24.7 scores on a scale
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Biomarkers of inflammation reported as troponin I ultra-sensitive
Outcome measures
| Measure |
MV ASV+OMT
n=42 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=44 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Biomarkers - Inflammation
|
-13.3 ng/mL
Standard Deviation 32.1
|
-14.1 ng/mL
Standard Deviation 41.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Biomarkers of cardiovascular function reported as hs-CRP
Outcome measures
| Measure |
MV ASV+OMT
n=42 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=44 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Biomarkers - Cardiovascular
|
0.03 mg/L
Standard Deviation 0.6
|
0.29 mg/L
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Biomarkers of renal function reported as creatinine
Outcome measures
| Measure |
MV ASV+OMT
n=24 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=18 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Biomarkers - Renal Function
|
0.18 mg/dL
Standard Deviation 0.66
|
0.08 mg/dL
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).
Outcome measures
| Measure |
MV ASV+OMT
n=41 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=37 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
ECHO Parameters - LVEF
|
3.8 %EF
Standard Deviation 6.3
|
5.0 %EF
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).
Outcome measures
| Measure |
MV ASV+OMT
n=38 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=35 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
ECHO Parameters - LVESVI
|
-9.0 mL/m^2
Standard Deviation 21.1
|
-8.6 mL/m^2
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis. HFrEF and HFpEF subjects were separated accordingly.
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFpEF (heart failure with preserved ejection fraction).
Outcome measures
| Measure |
MV ASV+OMT
n=39 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=39 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
ECHO Parameters - E/e' Ratio
Change in E/e' (HFpEF)
|
-2.1 ratio
Standard Deviation 9.0
|
-4.6 ratio
Standard Deviation 6.7
|
|
ECHO Parameters - E/e' Ratio
Change in E/e' (HFrEF)
|
-3.2 ratio
Standard Deviation 9.6
|
-2.6 ratio
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 6 monthsPatients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labeled a 'winner' or a 'loser' depending on who had a CV death first. If that is not known, they are labeled a 'winner' or 'loser' depending on who had a HF hospitalization first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers.
Outcome measures
| Measure |
MV ASV+OMT
n=126 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Win Ratio
|
0.97 Ratio
Interval 0.59 to 1.61
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: Not all subjects in the active arm successfully measured ODI. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)
Outcome measures
| Measure |
MV ASV+OMT
n=58 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=42 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Sleep Parameters
Change in AHI
|
-33.7 events per hour
Standard Deviation 16.9
|
-17.9 events per hour
Standard Deviation 22.3
|
|
Sleep Parameters
Change in ODI
|
-28.3 events per hour
Standard Deviation 17.5
|
-16.3 events per hour
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: 2 days, 1 week, 1, 2, 3, and 6 monthsRates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason
Outcome measures
| Measure |
MV ASV+OMT
n=65 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Number of Subjects With HF Hospitalization
|
34 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 2 days, 1 week, 1, 2, 3, and 6 monthsRate of Cardiovascular and all-cause death
Outcome measures
| Measure |
MV ASV+OMT
n=65 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Death
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTotal days dead or hospitalized at study end
Outcome measures
| Measure |
MV ASV+OMT
n=65 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Time Dead/Hospitalized
|
23.9 number of days
Standard Deviation 39.3
|
24.1 number of days
Standard Deviation 42.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
The Duke Activity Status Index is a 12-item patient-reported outcome validated for the assessment of functional capacity based on the ability to perform everyday activities. With a total range of 0 to 58.20, a higher score indicates better quality of life.
Outcome measures
| Measure |
MV ASV+OMT
n=52 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=49 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
DASI
|
3.7 scores on a scale
Standard Deviation 13.4
|
5.2 scores on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
The EQ-5D-5L is a standardized self-report questionnaire that is used as a measure of health outcome. The EQ-5D-5L questionnaire is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses were indexed using the EQ-5D-5L US value set to scale the 5 dimensions. A score of -0.109 indicates extreme problems for all dimensions and a score of 1.000 indicates no problems for all dimensions. Therefore, a higher score indicates better general health.
Outcome measures
| Measure |
MV ASV+OMT
n=51 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
EQ-5D-5L Index
|
0.07 scores on a scale
Standard Deviation 0.23
|
0.03 scores on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the following scoring severity index: 0 - Not at all, 1 - Several Days, 2 - More than Half the Days, 3 - Nearly Every Day. Total score can range from 0 to 27. A higher score indicates increased severity.
Outcome measures
| Measure |
MV ASV+OMT
n=52 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=49 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
PHQ-9
|
-2.8 scores on a scale
Standard Deviation 6.7
|
-4.6 scores on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
The Pittsburgh Sleep Quality Index is a 19-item subjective measurement of sleep. It is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. The subject self-rates each of these seven areas of sleep. The seven component scores are then added to yield a total score with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Outcome measures
| Measure |
MV ASV+OMT
n=48 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=48 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
PSQI
|
-2.7 scores on a scale
Standard Deviation 5.0
|
-3.3 scores on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsPopulation: For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.
The Epworth Sleepiness Scale is a simple, 8-item self-administered questionnaire which provides a measurement of the subject's general level of daytime sleepiness. The individual is asked on a scale of 0-3 to score the likelihood of falling asleep in eight various situations. With a total range of 0 to 24, a higher score indicates increased severity.
Outcome measures
| Measure |
MV ASV+OMT
n=51 Participants
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=48 Participants
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
ESS
|
-1.6 scores on a scale
Standard Deviation 5.6
|
-2.1 scores on a scale
Standard Deviation 5.1
|
Adverse Events
MV ASV+OMT
OMT Only
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MV ASV+OMT
n=58 participants at risk；n=65 participants at risk
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV: Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
OMT Only
n=61 participants at risk
Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.
Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bloating
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/61 • 6 months
|
|
Cardiac disorders
Weight gain
|
0.00%
0/58 • 6 months
|
1.6%
1/61 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/61 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place