| Primary | 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. | | Posted | | Mean | Standard Deviation | Standardized global rank order value | | Baseline, 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00050.4± 28.3
- OG00149.6± 30.0
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects. | Wilcoxon (Mann-Whitney) | | 0.916 | | | | | | | | | | | | | | Other | The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang. |
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| Secondary | Six-minute Walk Distance | Change in functional parameters as measured by 6-minute walk test (6MWT) | 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. | Posted | | Mean | Standard Deviation | meters | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | NT Pro-BNP | Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Biomarkers - Inflammation | Biomarkers of inflammation reported as troponin I ultra-sensitive | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Biomarkers - Cardiovascular | Biomarkers of cardiovascular function reported as hs-CRP | 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. | Posted | | Mean | Standard Deviation | mg/L | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Biomarkers - Renal Function | Biomarkers of renal function reported as creatinine | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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). | 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. | Posted | | Mean | Standard Deviation | %EF | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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). | 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. | Posted | | Mean | Standard Deviation | mL/m^2 | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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). | 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. | Posted | | Mean | Standard Deviation | ratio | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | | Posted | | Number | 95% Confidence Interval | Ratio | | 6 months | | | | ID | Title | Description |
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| OG000 | All Subjects | Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment compared to optimized medical treatment only 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 |
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| Secondary | Sleep Parameters | Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia) | 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. | Posted | | Mean | Standard Deviation | events per hour | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Number of Subjects With HF Hospitalization | Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason | | Posted | | Count of Participants | | Participants | | 2 days, 1 week, 1, 2, 3, and 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Death | Rate of Cardiovascular and all-cause death | | Posted | | Count of Participants | | Participants | | 2 days, 1 week, 1, 2, 3, and 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Time Dead/Hospitalized | Total days dead or hospitalized at study end | | Posted | | Mean | Standard Deviation | number of days | | 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Change from Baseline to 6 months | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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