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This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape.
This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk reduction. The investigators also intend to measure the effects of valsartan/sacubitril on exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of valsartan/sacubitril on functional status and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that incorporates Fitbit technology to provide a "real time" daily 6 minute step count and assesses quality of life using a series of short targeted questions. The investigators will also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at multiple time-points throughout the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label Entresto | Other | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entresto | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) | LV Remodeling 2D End-Diastolic Diameter (cm) | Baseline,1 year |
| Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm) | LV Remodeling 2D End-Systolic Diameter (cm) | Baseline,1 year |
| Change From Baseline in LV Remodeling Global Longitudinal Strain (%) | LV Remodeling Global Longitudinal Strain (%) | Baseline,1 year |
| Change From Baseline in LV Remodeling Left Atrial Volume (mL) | LV Remodeling Left Atrial Volume (mL) | Baseline,1 year |
| Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL) | LV Remodeling 3D End-Diastolic Volume (mL) | Baseline,1 year |
| Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL) | LV Remodeling 3D End-Systolic Volume (mL) | Baseline,1 year |
| Change From Baseline in LV Remodeling LV Ejection Fraction (%) | LV Remodeling LV Ejection Fraction (%) | Baseline,1 year |
| Change From Baseline in LV Remodeling Conicity (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Rho-associated Protein Kinase (ROCK) | Rho-associated protein kinase (ROCK) | Baseline,1 year |
| Change From Baseline in (MIBG) Early hm Ratio | Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio |
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Inclusion Criteria:
Males and females aged ≥18 years
Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤ Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)
Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
Stable and optimized on a beta-blocker for at least 4 weeks
Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Kalantari, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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This is a prospective, single-arm longitudinal study, 40 patients were initiated on valsartan/sacubitril after a two week run in period of ACE or ARB alone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Entresto | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care. Entresto |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Entresto | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care. Entresto |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) | LV Remodeling 2D End-Diastolic Diameter (cm) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | cm | Baseline,1 year |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Entresto | REMODEL is a prospective, single-arm longitudinal study investigating the structural, neurohormonal and functional effects of sacubitril/valsartan. Patients with New York Heart Association (NYHA) Class II-III HFrEF who were on optimal guideline directed medical therapy for at least three months with an LVEF between 20-40% who otherwise met inclusion and exclusion criteria similar to that of the Paradigm Trial were eligible for enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment | Hypotension |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Kalantari, MD | University of Chicago | 773-834-6853 | skalantari@medicine.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2018 | Apr 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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LV Remodeling Conicity (%)
| Baseline,1 year |
| Change From Baseline in LV Remodeling Sphericity (%) | LV Remodeling Sphericity (%) | Baseline,1 year |
| Change From Baseline in RV Remodeling End-Diastolic Volume (mL) | RV Remodeling End-Diastolic Volume (mL) | Baseline,1 year |
| Change From Baseline in RV Remodeling End Systolic Volume (mL) | RV Remodeling End Systolic Volume (mL) | Baseline,1 year |
| Change From Baseline in RV Remodeling Ejection Fraction (%) | RV Remodeling Ejection Fraction (%) | Baseline,1 year |
| Change From Baseline in RV Remodeling Septal Curvature (%) | RV Remodeling Septal Curvature (%) | Baseline,1 year |
| Change From Baseline in RV Remodeling Free-Wall Curvature (%) | RV Remodeling Free-Wall Curvature (%) | Baseline,1 year |
| Change From Baseline in RV Remodeling Tricuspid Regurgitation | RV Remodeling Tricuspid Regurgitation | Baseline,1 year |
| Baseline,1 year |
| Change From Baseline in (MIBG) Late hm Ratio | Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio | Baseline,1 year |
| Change From Baseline in NT-proBNP Levels | NT-proBNP levels (pg/ml) | Baseline,1 year |
| Change From Baseline in Exercise Performance - 6 Minute Walk | Exercise Performance - 6 Minute Walk | Baseline,1 year |
| Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min) | Exercise Performance - CPX - Peak VO2 (mL/kg/min) | Baseline,1 year |
| Change From Baseline in Exercise Performance - CPX - Peak RER | Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio) | Baseline,1 year |
| Change From Baseline in Exercise Performance - CPX - VE/VC02 | Exercise Performance - CPX - VE/VC02 | Baseline,1 year |
| Change From Baseline in Blood Pressure - Systolic (mmHg) | Blood Pressure - Systolic (mmHg) | Baseline,1 year |
| Change From Baseline in Blood Pressure - Diastolic (mmHg) | Blood Pressure - Diastolic (mmHg) | Baseline,1 year |
| Change From Baseline in KCCQ - Physical Limitation | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Symptom Stability | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Symptom Frequency | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Symptom Burden | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Total Symptom | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Self Efficacy | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Quality of Life Score | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Social Limitation | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Overall Summary | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Change From Baseline in KCCQ - Clinical Summary | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Baseline,1 year |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Class | New York Heart Association (NYHA) Functional Classification. I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, shortness of breath (SOB). II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, SOB. III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or SOB. IV: Unable to do any physical activity without discomfort. Symptoms of heart failure at rest. | Count of Participants | Participants |
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| Heart Failure Etiology | Count of Participants | Participants |
|
| LV Remodeling | Mean | Standard Deviation | percent |
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| LV Remodeling-Global Longitudinal Strain (%) | Mean | Standard Deviation | percent |
|
| LV Remodeling | Some patients have incomplete data. | Median | Inter-Quartile Range | mL |
|
| LV Remodeling | Mean | Standard Deviation | cm |
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| RV Remodeling | Median | Inter-Quartile Range | cm |
|
| RV Remodeling | Mean | Standard Deviation | percent |
|
| RV Remodeling - Free-Wall Curvature | Median | Inter-Quartile Range | percent |
|
| RV Remodeling - Tricuspid Regurgitation | Count of Participants | Participants |
|
| Exercise Performance- 6 Minute Walk | Mean | Standard Deviation | Meter |
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| Exercise Performance - CPX -Peak RER | Mean | Standard Deviation | meters |
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| Exercise Performance - CPX - Peak VO2 | Median | Inter-Quartile Range | mL/kg/min |
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| Exercise Performance - CPX - VE/VC02 | Median | Inter-Quartile Range | ratio |
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| Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Rho-kinase (Rock) | Median | Inter-Quartile Range | ng/mL |
|
| hm ratio | Some patients have incomplete data. | Median | Inter-Quartile Range | ratio |
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| NT-proBNP levels | Median | Inter-Quartile Range | pg/mL |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | Clinical Summary Score is the sum of total symptom and physical function, and then rescaled to range from 0-100. Overall Summary Score is sum of total symptom, physical function, social limitations, and quality of life scores, and then rescaled to range from 0-100. Some patients had incomplete data. | Median | Inter-Quartile Range | scores on a scale |
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| Participants |
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| Primary | Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm) | LV Remodeling 2D End-Systolic Diameter (cm) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | cm | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling Global Longitudinal Strain (%) | LV Remodeling Global Longitudinal Strain (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of global longitudinal strain | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling Left Atrial Volume (mL) | LV Remodeling Left Atrial Volume (mL) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL) | LV Remodeling 3D End-Diastolic Volume (mL) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL) | LV Remodeling 3D End-Systolic Volume (mL) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling LV Ejection Fraction (%) | LV Remodeling LV Ejection Fraction (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of ejection fraction | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling Conicity (%) | LV Remodeling Conicity (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of conicity | Baseline,1 year |
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| Primary | Change From Baseline in LV Remodeling Sphericity (%) | LV Remodeling Sphericity (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of sphericity | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling End-Diastolic Volume (mL) | RV Remodeling End-Diastolic Volume (mL) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling End Systolic Volume (mL) | RV Remodeling End Systolic Volume (mL) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling Ejection Fraction (%) | RV Remodeling Ejection Fraction (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of ejection fraction | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling Septal Curvature (%) | RV Remodeling Septal Curvature (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | percentage of septal curvature | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling Free-Wall Curvature (%) | RV Remodeling Free-Wall Curvature (%) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | percentage of free-wall curvature | Baseline,1 year |
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| Primary | Change From Baseline in RV Remodeling Tricuspid Regurgitation | RV Remodeling Tricuspid Regurgitation | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Count of Participants | Participants | Baseline,1 year |
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| Secondary | Change From Baseline in Rho-associated Protein Kinase (ROCK) | Rho-associated protein kinase (ROCK) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | ng/mL | Baseline,1 year |
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| Secondary | Change From Baseline in (MIBG) Early hm Ratio | Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 0 participants analyzed at 1 year as data were not collected. | Posted | Median | Inter-Quartile Range | ratio | Baseline,1 year |
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| Secondary | Change From Baseline in (MIBG) Late hm Ratio | Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 0 participants analyzed at 1 year as data were not collected | Posted | Median | Inter-Quartile Range | ratio | Baseline,1 year |
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| Secondary | Change From Baseline in NT-proBNP Levels | NT-proBNP levels (pg/ml) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | pg/ml | Baseline,1 year |
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| Secondary | Change From Baseline in Exercise Performance - 6 Minute Walk | Exercise Performance - 6 Minute Walk | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | meters | Baseline,1 year |
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| Secondary | Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min) | Exercise Performance - CPX - Peak VO2 (mL/kg/min) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mL/kg/min | Baseline,1 year |
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| Secondary | Change From Baseline in Exercise Performance - CPX - Peak RER | Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Mean | Standard Deviation | ratio | Baseline,1 year |
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| Secondary | Change From Baseline in Exercise Performance - CPX - VE/VC02 | Exercise Performance - CPX - VE/VC02 | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | ratio | Baseline,1 year |
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| Secondary | Change From Baseline in Blood Pressure - Systolic (mmHg) | Blood Pressure - Systolic (mmHg) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mmHg | Baseline,1 year |
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| Secondary | Change From Baseline in Blood Pressure - Diastolic (mmHg) | Blood Pressure - Diastolic (mmHg) | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | mmHg | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Physical Limitation | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Symptom Stability | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Symptom Frequency | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Symptom Burden | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Total Symptom | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Self Efficacy | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Quality of Life Score | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Social Limitation | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Overall Summary | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| Secondary | Change From Baseline in KCCQ - Clinical Summary | KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City. | All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline,1 year |
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| 0 |
| 40 |
| 4 |
| 40 |
| 4 |
| 40 |
Not provided
Not provided
Not provided
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| Mild |
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| Mild-Moderate |
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| Moderate |
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| Moderate-Severe |
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| Severe |
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| 1 year |
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