Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-09 @ 3:11 AM
Study NCT ID:
NCT02754518
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
Sponsor:
Organization:
Raw JSON
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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling 3D End-Diastolic Volume (mL)', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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In this study subjects will take this drug as they normally would for their standard of care.\n\nEntresto'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'pValueComment': 'P-values are not adjusted for multiple comparisons. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling Free-Wall Curvature (%)', 'unitOfMeasure': 'percentage of free-wall curvature', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in RV Remodeling Tricuspid Regurgitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'Rho-associated protein kinase (ROCK)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in (MIBG) Early hm Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'NT-proBNP levels (pg/ml)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Performance - 6 Minute Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': '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.\n\nEntresto'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '425', 'spread': '102', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '486', 'spread': '124', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - 6 Minute Walk', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - Peak VO2 (mL/kg/min)', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Performance - CPX - Peak RER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Performance - CPX - VE/VC02', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - VE/VC02', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure - Systolic (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': 'Blood Pressure - Systolic (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure - Diastolic (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in KCCQ - Symptom Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in KCCQ - Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Subscales and Total Score range from 0-100; higher scores show better health status.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in KCCQ - Self Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in KCCQ - Overall Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Entresto', 'description': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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. 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Tests were two-tailed, considered statistically significant with a p-value \\<0.05, and conducted using STATA MP version 15 (College Station, TX).', 'groupDescription': 'Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Entresto', 'description': '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.\n\nEntresto'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label Entresto', 'description': '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.\n\nEntresto'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association (NYHA) Class', 'classes': [{'title': 'Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA) Functional Classification.\n\nI: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, shortness of breath (SOB).\n\nII: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, SOB.\n\nIII: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or SOB.\n\nIV: Unable to do any physical activity without discomfort. 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'BG000'}]}]}, {'title': 'Conicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.03', 'groupId': 'BG000'}]}]}, {'title': 'Sphericity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Remodeling-Global Longitudinal Strain (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Remodeling', 'classes': [{'title': 'Left Atrial Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'BG000', 'lowerLimit': '67.7', 'upperLimit': '111.1'}]}]}, {'title': '3D End-Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '243.5', 'groupId': 'BG000', 'lowerLimit': '190.1', 'upperLimit': '302.1'}]}]}, {'title': '3D End-Systolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '159.7', 'groupId': 'BG000', 'lowerLimit': '118.9', 'upperLimit': '207.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Some patients have incomplete data.'}, {'title': 'LV Remodeling', 'classes': [{'title': '2D End-Diastolic Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.8', 'groupId': 'BG000'}]}]}, {'title': '2D End-Systolic Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RV Remodeling', 'classes': [{'title': 'End-Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000', 'lowerLimit': '121', 'upperLimit': '174'}]}]}, {'title': 'End Systolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '97'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'RV Remodeling', 'classes': [{'title': 'Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '10', 'groupId': 'BG000'}]}]}, {'title': 'Septal Curvature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RV Remodeling - Free-Wall Curvature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'BG000', 'lowerLimit': '1.09', 'upperLimit': '1.22'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'RV Remodeling - Tricuspid Regurgitation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Trace', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Mild-Moderate', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Moderate-Severe', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Exercise Performance- 6 Minute Walk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '425', 'spread': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exercise Performance - CPX -Peak RER', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exercise Performance - CPX - Peak VO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'BG000', 'lowerLimit': '13.7', 'upperLimit': '22.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Exercise Performance - CPX - VE/VC02', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Blood Pressure', 'classes': [{'title': 'Systolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '127', 'spread': '22.6', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '76', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rho-kinase (Rock)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0.7', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'hm ratio', 'classes': [{'title': '(MIBG) Early hm ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'BG000', 'lowerLimit': '1.34', 'upperLimit': '1.61'}]}]}, {'title': '(MIBG) Late hm ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.43', 'groupId': 'BG000', 'lowerLimit': '1.27', 'upperLimit': '1.53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Some patients have incomplete data.'}, {'title': 'NT-proBNP levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '333', 'groupId': 'BG000', 'lowerLimit': '130', 'upperLimit': '1003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'classes': [{'title': 'Physical limitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '71', 'upperLimit': '100'}]}]}, {'title': 'Symptom Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000', 'lowerLimit': '74', 'upperLimit': '100'}]}]}, {'title': 'Symptom Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000', 'lowerLimit': '79', 'upperLimit': '100'}]}]}, {'title': 'Total Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000', 'lowerLimit': '71.5', 'upperLimit': '100'}]}]}, {'title': 'Self Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': 'Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '83'}]}]}, {'title': 'Social Limitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '94'}]}]}, {'title': 'Overall Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '90'}]}]}, {'title': 'Clinical Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000', 'lowerLimit': '72', 'upperLimit': '98'}]}]}], 'paramType': 'MEDIAN', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '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.\n\nSome patients had incomplete data.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-25', 'size': 658451, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-09T15:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2016-04-22', 'resultsFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-05', 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling 2D End-Diastolic Diameter (cm)'}, {'measure': 'Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling 2D End-Systolic Diameter (cm)'}, {'measure': 'Change From Baseline in LV Remodeling Global Longitudinal Strain (%)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling Global Longitudinal Strain (%)'}, {'measure': 'Change From Baseline in LV Remodeling Left Atrial Volume (mL)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling Left Atrial Volume (mL)'}, {'measure': 'Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling 3D End-Diastolic Volume (mL)'}, {'measure': 'Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling 3D End-Systolic Volume (mL)'}, {'measure': 'Change From Baseline in LV Remodeling LV Ejection Fraction (%)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling LV Ejection Fraction (%)'}, {'measure': 'Change From Baseline in LV Remodeling Conicity (%)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling Conicity (%)'}, {'measure': 'Change From Baseline in LV Remodeling Sphericity (%)', 'timeFrame': 'Baseline,1 year', 'description': 'LV Remodeling Sphericity (%)'}, {'measure': 'Change From Baseline in RV Remodeling End-Diastolic Volume (mL)', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling End-Diastolic Volume (mL)'}, {'measure': 'Change From Baseline in RV Remodeling End Systolic Volume (mL)', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling End Systolic Volume (mL)'}, {'measure': 'Change From Baseline in RV Remodeling Ejection Fraction (%)', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling Ejection Fraction (%)'}, {'measure': 'Change From Baseline in RV Remodeling Septal Curvature (%)', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling Septal Curvature (%)'}, {'measure': 'Change From Baseline in RV Remodeling Free-Wall Curvature (%)', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling Free-Wall Curvature (%)'}, {'measure': 'Change From Baseline in RV Remodeling Tricuspid Regurgitation', 'timeFrame': 'Baseline,1 year', 'description': 'RV Remodeling Tricuspid Regurgitation'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Rho-associated Protein Kinase (ROCK)', 'timeFrame': 'Baseline,1 year', 'description': 'Rho-associated protein kinase (ROCK)'}, {'measure': 'Change From Baseline in (MIBG) Early hm Ratio', 'timeFrame': 'Baseline,1 year', 'description': 'Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio'}, {'measure': 'Change From Baseline in (MIBG) Late hm Ratio', 'timeFrame': 'Baseline,1 year', 'description': 'Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio'}, {'measure': 'Change From Baseline in NT-proBNP Levels', 'timeFrame': 'Baseline,1 year', 'description': 'NT-proBNP levels (pg/ml)'}, {'measure': 'Change From Baseline in Exercise Performance - 6 Minute Walk', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - 6 Minute Walk'}, {'measure': 'Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min)', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - Peak VO2 (mL/kg/min)'}, {'measure': 'Change From Baseline in Exercise Performance - CPX - Peak RER', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)'}, {'measure': 'Change From Baseline in Exercise Performance - CPX - VE/VC02', 'timeFrame': 'Baseline,1 year', 'description': 'Exercise Performance - CPX - VE/VC02'}, {'measure': 'Change From Baseline in Blood Pressure - Systolic (mmHg)', 'timeFrame': 'Baseline,1 year', 'description': 'Blood Pressure - Systolic (mmHg)'}, {'measure': 'Change From Baseline in Blood Pressure - Diastolic (mmHg)', 'timeFrame': 'Baseline,1 year', 'description': 'Blood Pressure - Diastolic (mmHg)'}, {'measure': 'Change From Baseline in KCCQ - Physical Limitation', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Symptom Stability', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Symptom Frequency', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Symptom Burden', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Total Symptom', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Self Efficacy', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Quality of Life Score', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Social Limitation', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Overall Summary', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}, {'measure': 'Change From Baseline in KCCQ - Clinical Summary', 'timeFrame': 'Baseline,1 year', 'description': '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.\n\nDeveloped and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females aged ≥18 years\n2. 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)\n\n * NT-proBNP ≥ 600 pg/mL OR\n * NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12 months\n3. Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks\n4. Stable and optimized on a beta-blocker for at least 4 weeks\n5. Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks\n\nExclusion Criteria:\n\n1. History of angioedema\n2. estimated glomerular filtration rate (eGFR) \\< 30 ml/min/1.73 m2 at screening\n3. Serum potassium \\> 5.2 mmol/L at screening\n4. Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) \\< 100 mmHg at screening\n5. Current acute decompensated heart failure\n6. History of severe pulmonary disease\n7. Active malignancy\n8. Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and angiotensin receptor blockers (ARB)'}, 'identificationModule': {'nctId': 'NCT02754518', 'briefTitle': 'Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) Using Echocardiography Endocardial Surface Analysis', 'orgStudyIdInfo': {'id': 'IRB15-1410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open label Entresto', 'description': '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.', 'interventionNames': ['Drug: Entresto']}], 'interventions': [{'name': 'Entresto', 'type': 'DRUG', 'otherNames': ['valsartan/sacubitril'], 'armGroupLabels': ['Open label Entresto']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Sara Kalantari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}