| Primary | CV Death or Heart Failure Hospitalization | Composite of First Heart Failure Hospitalization or Cardiovascular Mortality | | Posted | | Number | | events | | 24 Months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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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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| | Regression, Cox | | 0.88 | A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM. | Hazard Ratio (HR) | 0.98 | | | 2-Sided | 95 | 0.79 | 1.22 | | | | | Superiority or Other | | |
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| Secondary | All-cause Mortality | All-cause mortality by treatment arm | | Posted | | Number | | deaths | | 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Cumulative Morbidity | Days alive and not hospitalized for CV reasons | | Posted | | Mean | 95% Confidence Interval | days | | 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | CV Death | CV death by treatment arm | | Posted | | Number | | deaths | | 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Number of Hospitalizations for First Heart Failure | First Heart Failure Hospitalization | | Posted | | Number | | hospitalizations | | 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Number of Hospitalizations for Recurrent Heart Failure | Recurrent Heart Failure Hospitalization | | Posted | | Number | | hospitalizations | | 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Percentage of Patients With Moderate to Severe Depression | Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Number | | percentage of participants | | Baseline, 3,6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Duke Activity Status Index (DASI) | The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | EQ-5D Health Index | The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best). | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | EQ-5D Visual Analog Scale | The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state. | | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score | This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6,12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Short Form-36 (SF-36) General Health Subscale | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Short Form-36 (SF-36) Mental Health Subscale | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Short Form-36 (SF-36) Social Functioning Subscale | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Short Form-36 (SF-36) Physiological Functioning Subscale | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Short Form-36 (SF-36) Vitality Subscale | SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life. | "Number of participants analyzed" is the number of participants who completed the questionnaire | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3, 6, 12 and 24 months | | | | ID | Title | Description |
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| OG000 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care | | OG001 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP |
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| Secondary | Resource Utilization | | US Patients in Economics Substudy | Posted | | Mean | Standard Deviation | events | | 24 months | | | | ID | Title | Description |
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| OG000 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP | | OG001 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care |
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| Secondary | Resource Utilization Cost | Observed Hospital-Based Cost. | US Patients with billing data | Posted | | Mean | Standard Deviation | 2016 US dollars | | 24 months | | | | ID | Title | Description |
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| OG000 | Biomarker-Guided Care | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Biomarker-guided care NT-proBNP: Device: NT-proBNP | | OG001 | Usual Care | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Usual Care: Usual Care |
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