Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-07 @ 12:04 PM
Study NCT ID:
NCT03200860
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.a.voors@umcg.nl', 'phone': '0031503616161', 'title': 'Prof. dr. A.A. Voors', 'organization': 'University Medical Center Groningen - Department of Cardiology'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '* Limited number of patients\n* Screened many more patients then were included\n* no standardized protocol for inhospital treatment for HF'}}, 'adverseEventsModule': {'timeFrame': '60 days', 'eventGroups': [{'id': 'EG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 29, 'seriousNumAtRisk': 40, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 31, 'seriousNumAtRisk': 39, 'deathsNumAffected': 3, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Renal Function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'S. Aureus Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1264', 'spread': '1211', 'groupId': 'OG000'}, {'value': '1650', 'spread': '1240', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 4', 'description': 'Change in Dyspnea on VAS analogue scale (AUC)\n\nVAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect).\n\nThe change in Dyspnea VAS means higher score is better outcomes.\n\nIndividual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated', 'unitOfMeasure': 'mmxh', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Diuretic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Total weight change from baseline to Day 4', 'description': 'Weight change from baseline per 40 mg of Furosemide equivalent', 'unitOfMeasure': 'kg/40 mg Furosemide equivalent at day 4', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 60 days', 'description': 'Hospital stay of Index admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma NTproBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-46', 'spread': '32', 'groupId': 'OG000'}, {'value': '-42', 'spread': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 4', 'description': 'Change in NTproBNP', 'unitOfMeasure': '% change in NTproBNP at day 4', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death and/or Heart Failure Re-admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Death and/or heart failure re-admission at day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 day', 'description': 'All Cause Mortality at 60 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'classes': [{'title': 'Cardiovascular', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory/Pulmonary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Renal/Urinary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infectious', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'All Cause Mortality', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'SAE including all cause mortality. Per request Clintrials.gov different from Protocol definition', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days\n\nEmpagliflozin 10 MG: 10 mg daily, oral, 30 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days\n\nPlacebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000', 'lowerLimit': '73', 'upperLimit': '83'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '83'}, {'value': '76', 'groupId': 'BG002', 'lowerLimit': '68', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NTproBNP', 'classes': [{'categories': [{'measurements': [{'value': '4406', 'groupId': 'BG000', 'lowerLimit': '2873', 'upperLimit': '6979'}, {'value': '6168', 'groupId': 'BG001', 'lowerLimit': '3180', 'upperLimit': '10489'}, {'value': '4918', 'groupId': 'BG002', 'lowerLimit': '3062', 'upperLimit': '9555'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-20', 'size': 417104, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-09T08:45', 'hasProtocol': True}, {'date': '2019-09-03', 'size': 463151, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-09T08:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind, placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, placebo-controlled, double-blind, parallel group, multicenter study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2017-06-23', 'resultsFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-09', 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '60 days', 'description': 'SAE including all cause mortality. Per request Clintrials.gov different from Protocol definition'}], 'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'From baseline to Day 4', 'description': 'Change in Dyspnea on VAS analogue scale (AUC)\n\nVAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect).\n\nThe change in Dyspnea VAS means higher score is better outcomes.\n\nIndividual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated'}, {'measure': 'Diuretic Response', 'timeFrame': 'Total weight change from baseline to Day 4', 'description': 'Weight change from baseline per 40 mg of Furosemide equivalent'}, {'measure': 'Length of Stay', 'timeFrame': 'within 60 days', 'description': 'Hospital stay of Index admission'}, {'measure': 'Plasma NTproBNP', 'timeFrame': 'From baseline to Day 4', 'description': 'Change in NTproBNP'}], 'secondaryOutcomes': [{'measure': 'Death and/or Heart Failure Re-admission', 'timeFrame': 'Day 30', 'description': 'Death and/or heart failure re-admission at day 30'}, {'measure': 'Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60', 'timeFrame': '60 days', 'description': 'Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60'}, {'measure': 'All Cause Mortality', 'timeFrame': '60 day', 'description': 'All Cause Mortality at 60 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'diuretic response', 'empagliflozin'], 'conditions': ['Heart Failure Acute', 'Heart Failure，Congestive', 'Heart Failure; With Decompensation']}, 'referencesModule': {'references': [{'pmid': '26378978', 'type': 'BACKGROUND', 'citation': 'Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.'}, {'pmid': '27299675', 'type': 'BACKGROUND', 'citation': 'Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes,\n\nThis is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.\n\nTreatment will be continued until 30 days after index event, and primary efficacy measurements will be carried out during hospitalization and safety events until 60 days after index hospitalisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female \\>18 years of age; Women of non-child-bearing potential must have a documentation of surgical sterilization (hysterectomy and/or bilateral oophorectomy) OR must have experienced menopause (no menses for \\>12 months). Women of child bearing potential must have a negative pregnancy test, AND must use highly effective methods of contraception during treatment with IP plus 5 days after the end of study drug administration.\n* Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:\n\n 1. Dyspnea at rest or with minimal exertion\n 2. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph\n 3. BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL (for patients with AF: BNP≥500 pg/mL or NT-proBNP ≥2,000 pg/mL)\n 4. Treated with loop diuretics at screening\n* Able to be randomized within 24 hours from presentation to the hospital\n* Able and willing to provide freely given written informed consent\n* eGFR (CKD-EPI) ≥30 ml/min/1.73m2 between presentation and randomization\n\nExclusion Criteria:\n\n* Diabetes Mellitus Type I\n* Dyspnea primarily due to non-cardiac causes\n* Cardiogenic shock\n* Acute coronary syndrome within 30 days prior to randomization\n* Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization\n* Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH\\>7.30 and glucose \\>15 mmol/L and HCO3\\>18 mmol/L)\n* Pregnant or nursing (lactating) women\n* Current participation in any interventional study\n* Inability to follow instructions or comply with follow-up procedures\n* Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT03200860', 'acronym': 'EMPA-RESPONSE', 'briefTitle': 'Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Randomized, Double Blind, Placebo Controlled, Multicenter Pilot Study on the Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure (EMPA-RESPONSE-AHF)', 'orgStudyIdInfo': {'id': '2017-001679-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin', 'description': 'Empagliflozin 10 mg daily, oral, 30 days', 'interventionNames': ['Drug: Empagliflozin 10 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo 10 mg daily, oral, 30 days', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Empagliflozin 10 MG', 'type': 'DRUG', 'description': '10 mg daily, oral, 30 days', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Matching Placebo, 10 mg daily, oral, 30 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Emmen', 'state': 'Drenthe', 'country': 'Netherlands', 'facility': 'TREANT Zorggroep', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'ISALA Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Sneek', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Antonius Ziekenhuis', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Adriaan Voors, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}