An interventional study of MV ASV and Optimized Medical Treatment in Acute Decompensated Heart Failure and Sleep Disordered Breathing, sponsored by ResMed. Terminated at 15 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by ResMed · Not applicable, Interventional, and Supportive care
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.
This study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of MV-targeted ASV) in a 1:1 ratio.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 126 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.
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Hospital admission for acute decompensated HF as determined by:
Dyspnea at rest or with minimal exertion
Exclusion Criteria:
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
Device: MV ASV · Drug: Optimized Medical Treatment
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.
Drug: Optimized Medical Treatment
Minute ventilation-targeted servo-ventilation therapy.
Also known as: VPAP Adapt, AutoSet CS
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
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.
Time frame: Baseline, 6 months
Six-minute Walk Distance
Change in functional parameters as measured by 6-minute walk test (6MWT)
Time frame: Change from Baseline to 6 months
NT Pro-BNP
Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.
Time frame: Change from Baseline to 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Time frame: Change from Baseline to 6 months
Biomarkers - Inflammation
Biomarkers of inflammation reported as troponin I ultra-sensitive
Time frame: Change from Baseline to 6 months
Biomarkers - Cardiovascular
Biomarkers of cardiovascular function reported as hs-CRP
Time frame: Change from Baseline to 6 months
Biomarkers - Renal Function
Biomarkers of renal function reported as creatinine
Time frame: Change from Baseline to 6 months
ECHO Parameters - LVEF
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).
Time frame: Change from Baseline to 6 months
ECHO Parameters - LVESVI
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).
Time frame: Change from Baseline to 6 months
ECHO Parameters - E/e' Ratio
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).
Time frame: Change from Baseline to 6 months
Win Ratio
Patients 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.
Time frame: 6 months
Sleep Parameters
Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)
Time frame: Change from Baseline to 6 months
Number of Subjects With HF Hospitalization
Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason
Time frame: 2 days, 1 week, 1, 2, 3, and 6 months
Death
Rate of Cardiovascular and all-cause death
Time frame: 2 days, 1 week, 1, 2, 3, and 6 months
Time Dead/Hospitalized
Total days dead or hospitalized at study end
Time frame: 6 months
DASI
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.
Time frame: Change from Baseline to 6 months
EQ-5D-5L Index
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.
Time frame: Change from Baseline to 6 months
PHQ-9
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.
Time frame: Change from Baseline to 6 months
PSQI
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.
Time frame: Change from Baseline to 6 months
ESS
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.
Time frame: Change from Baseline to 6 months
| Milestone | MV ASV+OMT | OMT Only |
|---|---|---|
| Started | 65 | 61 |
| Completed | 65 | 61 |
| Not completed | 0 | 0 |
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.
| Standardized global rank order value | MV ASV+OMT | OMT Only |
|---|---|---|
| Global Rank Endpoint | 50.4 ± 28.3 | 49.6 ± 30.0 |
Change in functional parameters as measured by 6-minute walk test (6MWT)
| meters | MV ASV+OMT | OMT Only |
|---|---|---|
| Six-minute Walk Distance | 22.6 ± 131.3 | 61.2 ± 117.4 |
Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.
| pg/mL | MV ASV+OMT | OMT Only |
|---|---|---|
| NT Pro-BNP | 172.7 ± 3429.1 | -1069.9 ± 6768.2 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 20.3 ± 28.3 | 24.7 ± 28.0 |
Biomarkers of inflammation reported as troponin I ultra-sensitive
| ng/mL | MV ASV+OMT | OMT Only |
|---|---|---|
| Biomarkers - Inflammation | -13.3 ± 32.1 | -14.1 ± 41.8 |
Biomarkers of cardiovascular function reported as hs-CRP
| mg/L | MV ASV+OMT | OMT Only |
|---|---|---|
| Biomarkers - Cardiovascular | 0.03 ± 0.6 | 0.29 ± 1.6 |
Biomarkers of renal function reported as creatinine
| mg/dL | MV ASV+OMT | OMT Only |
|---|---|---|
| Biomarkers - Renal Function | 0.18 ± 0.66 | 0.08 ± 0.38 |
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).
| %EF | MV ASV+OMT | OMT Only |
|---|---|---|
| ECHO Parameters - LVEF | 3.8 ± 6.3 | 5.0 ± 9.5 |
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).
| mL/m^2 | MV ASV+OMT | OMT Only |
|---|---|---|
| ECHO Parameters - LVESVI | -9.0 ± 21.1 | -8.6 ± 16.2 |
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).
| ratio | MV ASV+OMT | OMT Only |
|---|---|---|
| Change in E/e' (HFpEF) | -2.1 ± 9.0 | -4.6 ± 6.7 |
| Change in E/e' (HFrEF) | -3.2 ± 9.6 | -2.6 ± 13.7 |
Patients 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.
| Ratio | All Subjects |
|---|---|
| Win Ratio | 0.97 (0.59 to 1.61) |
Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)
| events per hour | MV ASV+OMT | OMT Only |
|---|---|---|
| Change in AHI | -33.7 ± 16.9 | -17.9 ± 22.3 |
| Change in ODI | -28.3 ± 17.5 | -16.3 ± 20.5 |
Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason
| Participants | MV ASV+OMT | OMT Only |
|---|---|---|
| Number of Subjects With HF Hospitalization | 34 | 27 |
Rate of Cardiovascular and all-cause death
| Participants | MV ASV+OMT | OMT Only |
|---|---|---|
| Death | 4 | 7 |
Total days dead or hospitalized at study end
| number of days | MV ASV+OMT | OMT Only |
|---|---|---|
| Time Dead/Hospitalized | 23.9 ± 39.3 | 24.1 ± 42.8 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| DASI | 3.7 ± 13.4 | 5.2 ± 14.5 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| EQ-5D-5L Index | 0.07 ± 0.23 | 0.03 ± 0.22 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| PHQ-9 | -2.8 ± 6.7 | -4.6 ± 6.7 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| PSQI | -2.7 ± 5.0 | -3.3 ± 4.9 |
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.
| scores on a scale | MV ASV+OMT | OMT Only |
|---|---|---|
| ESS | -1.6 ± 5.6 | -2.1 ± 5.1 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MV ASV+OMT | 4/65 (6.2%) | 0/65 (0%) | 2/58 (3.4%) |
| OMT Only | 7/61 (11.5%) | 0/61 (0%) | 1/61 (1.6%) |
| Event | MV ASV+OMT | OMT Only |
|---|---|---|
| BloatingRespiratory, thoracic and mediastinal disorders | 1/58 | 0/61 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/58 | 0/61 |
| Weight gainCardiac disorders | 0/58 | 1/61 |
| Age, Continuous(years) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| Mean | 61.1 ± 13.5 | 63.2 ± 13.4 | 62.1 ± 13.4 |
| Sex: Female, Male(Participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| Female | 16 | 17 | 33 |
| Male | 49 | 44 | 93 |
| Ethnicity (NIH/OMB)(Participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 4 |
| Not Hispanic or Latino | 59 | 60 | 119 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 23 | 51 |
| White | 35 | 34 | 69 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| United States | 48 | 43 | 91 |
| Germany | 17 | 18 | 35 |
| Body mass index(kg/m^2) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| Mean | 32.3 ± 9.0 | 31.4 ± 8.6 | 31.9 ± 8.8 |
| New York Heart Association (NYHA) Class(Participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| NYHA Class I | 3 | 3 | 6 |
| NYHA Class II | 19 | 11 | 30 |
| NYHA Class III | 32 | 43 | 75 |
| NYHA Class IV | 9 | 3 | 12 |
| Not done | 2 | 1 | 3 |
| Left ventricular ejection fraction (LVEF)(Participants) | MV ASV+OMT | OMT Only | Total |
|---|---|---|---|
| Reduced ejection fraction (</=45%) | 52 | 50 | 102 |
| Preserved ejection fraction (>45%) | 13 | 11 | 24 |
7 further baseline measures are reported on the registry.
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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