Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 5:28 PM
Study NCT ID:
NCT03730961
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 100 days post-last dose (up to ca. 4 months)', 'eventGroups': [{'id': 'EG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'Sequence 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '900.7', 'spread': '366.56', 'groupId': 'OG000'}, {'value': '1603.3', 'spread': '674.18', 'groupId': 'OG001'}]}]}, {'title': 'Sequence 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1176.7', 'spread': '386.21', 'groupId': 'OG000'}, {'value': '1345.4', 'spread': '391.11', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1032.1', 'spread': '392.74', 'groupId': 'OG000'}, {'value': '1480.5', 'spread': '559.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-448', 'ciLowerLimit': '-714', 'ciUpperLimit': '-183', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Drug - placebo'}, {'pValue': '0.0222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.1', 'ciLowerLimit': '-40.7', 'ciUpperLimit': '-3.51', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change Drug - placebo'}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo.\n\nSequence 1: Placebo in period 1, drug in period 2\n\nSequence 2: Drug in period 1, placebo in period 2', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated (per Protocol set) - All randomized participants who were given both study treatments and completed the study as per protocol. Participants are included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'Before start of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '0-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': '4-5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': '5-6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': '6-7 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': '7-8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0163', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.25', 'ciLowerLimit': '-7.63', 'ciUpperLimit': '-0.876', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Drug - placebo, 0-4 hours after furosemide'}, {'pValue': '0.2018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-38.8', 'ciUpperLimit': '8.77', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change Drug - placebo, 0-4 hours after furosemide'}, {'pValue': '0.0526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.61', 'ciLowerLimit': '-7.27', 'ciUpperLimit': '0.0446', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Drug - placebo, 0-8 hours after start of infusion'}, {'pValue': '0.2076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-38.8', 'ciUpperLimit': '9', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change Drug - placebo, 0-8 hours after start of infusion'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours', 'description': 'Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo.\n\nFractional Excretion Na = ((Urine Sodium \\* Plasma Creatinine) / (Plasma Sodium \\* Urine Creatinine)) \\* 100', 'unitOfMeasure': 'percent of filtered sodium', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments.'}, {'type': 'SECONDARY', 'title': 'FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'Before start of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '0-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '4-5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': '5-6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': '6-7 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': '7-8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1621', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.431', 'ciLowerLimit': '-0.189', 'ciUpperLimit': '1.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Drug - placebo, 0-4 hours after furosemide'}, {'pValue': '0.0338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32', 'ciLowerLimit': '2.72', 'ciUpperLimit': '61.3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change Drug - placebo, 0-4 hours after furosemide'}, {'pValue': '0.0600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.766', 'ciLowerLimit': '-0.0353', 'ciUpperLimit': '1.57', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Drug - placebo, 0-8 hours after start of infusion'}, {'pValue': '0.0280', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.5', 'ciLowerLimit': '4.02', 'ciUpperLimit': '63', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change Drug - placebo, 0-8 hours after start of infusion'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours', 'description': 'Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo.\n\nFractional Excretion K = ((Urine Potassium \\* Plasma Creatinine) / (Plasma Potassium \\* Urine Creatinine)) \\* 100', 'unitOfMeasure': 'percent of filtered potassium', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments.'}, {'type': 'SECONDARY', 'title': 'Furosemide Urinary Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'Before start of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': '0-2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': '2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': '4-5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '4.56', 'groupId': 'OG001'}]}]}, {'title': '5-6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': '6-7 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': '7-8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': '8-10 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours', 'description': 'Summary of urine recovery by interval, measured by amount excreted.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments.'}, {'type': 'SECONDARY', 'title': 'Furosemide Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': '4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1605', 'spread': '5384', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '140.3', 'groupId': 'OG001'}]}]}, {'title': '5 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2049', 'spread': '593.0', 'groupId': 'OG000'}, {'value': '2145', 'spread': '653.2', 'groupId': 'OG001'}]}]}, {'title': '6 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1122', 'spread': '437.6', 'groupId': 'OG000'}, {'value': '1146', 'spread': '466.8', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '426.8', 'spread': '204.8', 'groupId': 'OG000'}, {'value': '476.6', 'spread': '226.0', 'groupId': 'OG001'}]}]}, {'title': '10 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '345.6', 'spread': '386.6', 'groupId': 'OG000'}, {'value': '244.3', 'spread': '164.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 4, 5, 6, 8, 10 hours', 'description': 'Summary of plasma concentrations by interval.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments.'}, {'type': 'SECONDARY', 'title': 'Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '4.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between drug and placebo', 'paramValue': '-4.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.74', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-4 hours after furosemide', 'description': 'Summary of urinary concentrations 0-4 hours after furosemide\n\nRatio = Cumulative Sodium Excretion / Cumulative Furosemide in Urine', 'unitOfMeasure': 'Ratio of Urinary Na:Urinary furosemide', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated (per Protocol set) - All randomized participants who were given both study treatments and completed the study as per protocol. Participants are included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Relevant Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 hours', 'description': 'Clinically relevant hypotension is defined as systolic blood pressure (SBP) \\< 90 mmHg or symptomatic hypotension during infusion', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 days', 'description': 'Clinically relevant hypotension is defined as systolic blood pressure (SBP) \\< 90 mmHg or symptomatic hypotension during infusion', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Abnormal Clinical Laboratory Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first dose to 30 days post-last dose (ca. 5-8 weeks)', 'description': 'Number of participants who experienced an in-study abnormal clinical laboratory event under the category of Hematology, Chemistry or Urinalysis.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'diastolic blood pressure', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '9.99', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '10.46', 'groupId': 'OG001'}]}]}, {'title': 'systolic blood pressure', 'categories': [{'measurements': [{'value': '-28.4', 'spread': '15.60', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '14.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.', 'unitOfMeasure': 'oxygen saturation percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiograms (ECGs) - Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '7.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for ECGs was reported for each arm.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiograms (ECGs) - PR, QRS Duration, QT, QTcF Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'title': 'PR Interval, Aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '24.21', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '12.17', 'groupId': 'OG001'}]}]}, {'title': 'QRS Duration, Aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '25.91', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '21.46', 'groupId': 'OG001'}]}]}, {'title': 'QT Interval, Aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '27.88', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '16.95', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval, Aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '26.90', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '16.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for ECGs was reported for each arm.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period.'}, {'type': 'SECONDARY', 'title': 'Telemetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'timeFrame': 'Day 1, 8 hours post-dose', 'description': 'Telemetry data not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is 0, data not collected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination - Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986231', 'description': 'BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for physical examinations was reported for each arm.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated (per Protocol set) - All randomized participants who were given both study treatments and completed the study as per protocol. Participants are included in the treatment group they received in each period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'First received placebo (period 1), then received BMS-986231 (period 2) following washout.\n\nEach treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'First received BMS-986231 (period 1), then received placebo (period 2) following washout.\n\nEach treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Initiated Period 1 treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Period 1 Completion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Period 2 Completion', 'achievements': [{'comment': '1 participant did not complete Period 2 due to hypotension but remained in the study', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': '1 participant discontinued study due to AE', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'comment': 'Completed study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '23 participants were randomized/assigned to treatment, and 23 initiated period 1 treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1', 'description': 'First received placebo (period 1), then received BMS-986231 (period 2) following washout.\n\nEach treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'id': 'BG001', 'title': 'Sequence 2', 'description': 'First received BMS-986231 (period 1), then received placebo (period 2) following washout.\n\nEach treatment administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes.'}, {'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': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '8.19', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '8.23', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '8.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', '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': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-15', 'size': 1235659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-10T17:14', 'hasProtocol': True}, {'date': '2020-01-22', 'size': 469255, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-10T17:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2018-11-01', 'resultsFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-06', 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo', 'timeFrame': '4 hours', 'description': 'The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo.\n\nSequence 1: Placebo in period 1, drug in period 2\n\nSequence 2: Drug in period 1, placebo in period 2'}], 'secondaryOutcomes': [{'measure': 'FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo', 'timeFrame': 'Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours', 'description': 'Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo.\n\nFractional Excretion Na = ((Urine Sodium \\* Plasma Creatinine) / (Plasma Sodium \\* Urine Creatinine)) \\* 100'}, {'measure': 'FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo', 'timeFrame': 'Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours', 'description': 'Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo.\n\nFractional Excretion K = ((Urine Potassium \\* Plasma Creatinine) / (Plasma Potassium \\* Urine Creatinine)) \\* 100'}, {'measure': 'Furosemide Urinary Concentrations', 'timeFrame': 'Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours', 'description': 'Summary of urine recovery by interval, measured by amount excreted.'}, {'measure': 'Furosemide Plasma Concentrations', 'timeFrame': 'Day 1: 4, 5, 6, 8, 10 hours', 'description': 'Summary of plasma concentrations by interval.'}, {'measure': 'Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion', 'timeFrame': '0-4 hours after furosemide', 'description': 'Summary of urinary concentrations 0-4 hours after furosemide\n\nRatio = Cumulative Sodium Excretion / Cumulative Furosemide in Urine'}, {'measure': 'Number of Participants With Clinically Relevant Hypotension', 'timeFrame': 'up to 8 hours', 'description': 'Clinically relevant hypotension is defined as systolic blood pressure (SBP) \\< 90 mmHg or symptomatic hypotension during infusion'}, {'measure': 'Number of Participants With an Adverse Event (AE)', 'timeFrame': 'up to 8 days', 'description': 'Clinically relevant hypotension is defined as systolic blood pressure (SBP) \\< 90 mmHg or symptomatic hypotension during infusion'}, {'measure': 'Number of Participants With an Abnormal Clinical Laboratory Value', 'timeFrame': 'from first dose to 30 days post-last dose (ca. 5-8 weeks)', 'description': 'Number of participants who experienced an in-study abnormal clinical laboratory event under the category of Hematology, Chemistry or Urinalysis.'}, {'measure': 'Change From Baseline in Vital Signs - Blood Pressure', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.'}, {'measure': 'Change From Baseline in Vital Signs - Heart Rate', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.'}, {'measure': 'Change From Baseline in Vital Signs - Oxygen Saturation', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for vital signs was reported for each arm.'}, {'measure': 'Change From Baseline in Electrocardiograms (ECGs) - Mean Heart Rate', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for ECGs was reported for each arm.'}, {'measure': 'Change From Baseline in Electrocardiograms (ECGs) - PR, QRS Duration, QT, QTcF Intervals', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for ECGs was reported for each arm.'}, {'measure': 'Telemetry', 'timeFrame': 'Day 1, 8 hours post-dose', 'description': 'Telemetry data not collected.'}, {'measure': 'Change From Baseline in Physical Examination - Body Weight', 'timeFrame': 'Day 1, 8 hours post-dose (end of infusion)', 'description': 'The change in baseline for physical examinations was reported for each arm.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Failure', 'Myocardial Failure', 'Congestive Heart Failure', 'Heart Decompensation']}, 'referencesModule': {'references': [{'pmid': '31168885', 'type': 'DERIVED', 'citation': "Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV. Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure. Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Left ventricular ejection fraction \\<45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months\n* On stable chronic guideline-directed therapy for HF including chronic loop diuretics, ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these medications in the past 2 weeks\n* At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg bumetamide)\n\nExclusion Criteria:\n\n* SBP \\< 115 mm Hg or \\> 180 mm Hg at screening or pre-randomization\n* Heart rate \\< 50 beats per minute (bpm) or \\> 120 bpm at screening or pre-randomization\n* Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03730961', 'briefTitle': 'An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Cross-over Phase 2 Study of Continuous 8-Hour Intravenous Infusions of BMS-986231 in Patients With Heart Failure and Impaired Systolic Function Given a Standard Dose of Loop Diuretic', 'orgStudyIdInfo': {'id': 'CV013-034'}, 'secondaryIdInfos': [{'id': '2018-000970-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo+Diuretic to BMS-986231+Diuretic', 'description': 'Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods', 'interventionNames': ['Drug: BMS-986231', 'Drug: Furosemide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986231+Diuretic to Placebo+Diuretic', 'description': 'Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods', 'interventionNames': ['Drug: BMS-986231', 'Drug: Furosemide', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-986231', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['BMS-986231+Diuretic to Placebo+Diuretic', 'Placebo+Diuretic to BMS-986231+Diuretic']}, {'name': 'Furosemide', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['BMS-986231+Diuretic to Placebo+Diuretic', 'Placebo+Diuretic to BMS-986231+Diuretic']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['BMS-986231+Diuretic to Placebo+Diuretic', 'Placebo+Diuretic to BMS-986231+Diuretic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Glasgow Clinical Research Facility', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Richmond Pharmacology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}