Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT03559868
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhibition of Sterile Inflammation by Digoxin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wajahat.mehal@yale.edu', 'phone': '877.925.3637', 'title': 'Mehal Wajahat MD, DPhil', 'organization': 'Yale University, Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'timeFrame': 'after starting digoxin', 'description': "Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data for this outcome was collected.'}, {'type': 'PRIMARY', 'title': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'timeFrame': '1 week after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data for this outcome was collected.'}, {'type': 'PRIMARY', 'title': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'timeFrame': '2 weeks after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data for this outcome was collected.'}, {'type': 'PRIMARY', 'title': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'timeFrame': '3 weeks after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data for this outcome was collected.'}, {'type': 'SECONDARY', 'title': 'Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'classes': [{'title': 'CCL2', 'categories': [{'measurements': [{'value': '697', 'spread': '237', 'groupId': 'OG000'}, {'value': '1351', 'spread': '483', 'groupId': 'OG001'}, {'value': '5790', 'spread': '2442', 'groupId': 'OG002'}]}]}, {'title': 'CCL4', 'categories': [{'measurements': [{'value': '1205', 'spread': '569', 'groupId': 'OG000'}, {'value': '12180', 'spread': '9763', 'groupId': 'OG001'}, {'value': '22328', 'spread': '7251', 'groupId': 'OG002'}]}]}, {'title': 'CCL20', 'categories': [{'measurements': [{'value': '894', 'spread': '490', 'groupId': 'OG000'}, {'value': '1205', 'spread': '569', 'groupId': 'OG001'}, {'value': '1761', 'spread': '471', 'groupId': 'OG002'}]}]}, {'title': 'CXCL1', 'categories': [{'measurements': [{'value': '312', 'spread': '232', 'groupId': 'OG000'}, {'value': '1437', 'spread': '340', 'groupId': 'OG001'}, {'value': '2909', 'spread': '725', 'groupId': 'OG002'}]}]}, {'title': 'CXCL10', 'categories': [{'measurements': [{'value': '366', 'spread': '293', 'groupId': 'OG000'}, {'value': '2472', 'spread': '886', 'groupId': 'OG001'}, {'value': '4452', 'spread': '1549', 'groupId': 'OG002'}]}]}, {'title': 'G-CSF', 'categories': [{'measurements': [{'value': '35', 'spread': '19', 'groupId': 'OG000'}, {'value': '211', 'spread': '80', 'groupId': 'OG001'}, {'value': '323', 'spread': '129', 'groupId': 'OG002'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '42', 'spread': '15', 'groupId': 'OG000'}, {'value': '142', 'spread': '39', 'groupId': 'OG001'}, {'value': '231', 'spread': '60', 'groupId': 'OG002'}]}]}, {'title': 'Granzyme B', 'categories': [{'measurements': [{'value': '182', 'spread': '60', 'groupId': 'OG000'}, {'value': '1117', 'spread': '684', 'groupId': 'OG001'}, {'value': '2734', 'spread': '1582', 'groupId': 'OG002'}]}]}, {'title': 'IFN Alpha', 'categories': [{'measurements': [{'value': '26', 'spread': '31', 'groupId': 'OG000'}, {'value': '97', 'spread': '61', 'groupId': 'OG001'}, {'value': '174', 'spread': '109', 'groupId': 'OG002'}]}]}, {'title': 'IFN Gamma', 'categories': [{'measurements': [{'value': '27', 'spread': '9', 'groupId': 'OG000'}, {'value': '103', 'spread': '82', 'groupId': 'OG001'}, {'value': '229', 'spread': '99', 'groupId': 'OG002'}]}]}, {'title': 'IL-RA', 'categories': [{'measurements': [{'value': '1074', 'spread': '290', 'groupId': 'OG000'}, {'value': '6040', 'spread': '1785', 'groupId': 'OG001'}, {'value': '12618', 'spread': '3485', 'groupId': 'OG002'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1064', 'spread': '427', 'groupId': 'OG000'}, {'value': '2797', 'spread': '831', 'groupId': 'OG001'}, {'value': '5006', 'spread': '1171', 'groupId': 'OG002'}]}]}, {'title': 'PDGF AA', 'categories': [{'measurements': [{'value': '238', 'spread': '294', 'groupId': 'OG000'}, {'value': '1519', 'spread': '773', 'groupId': 'OG001'}, {'value': '2848', 'spread': '135', 'groupId': 'OG002'}]}]}, {'title': 'PDGF AB/BB', 'categories': [{'measurements': [{'value': '128', 'spread': '75', 'groupId': 'OG000'}, {'value': '908', 'spread': '539', 'groupId': 'OG001'}, {'value': '1038', 'spread': '587', 'groupId': 'OG002'}]}]}, {'title': 'TNF Alpha', 'categories': [{'measurements': [{'value': '173', 'spread': '92', 'groupId': 'OG000'}, {'value': '2786', 'spread': '956', 'groupId': 'OG001'}, {'value': '4040', 'spread': '1004', 'groupId': 'OG002'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '117', 'spread': '41', 'groupId': 'OG000'}, {'value': '306', 'spread': '52', 'groupId': 'OG001'}, {'value': '420', 'spread': '24', 'groupId': 'OG002'}]}]}, {'title': 'Galactin 9', 'categories': [{'measurements': [{'value': '11977', 'spread': '4287', 'groupId': 'OG000'}, {'value': '20623', 'spread': '5876', 'groupId': 'OG001'}, {'value': '25999', 'spread': '2645', 'groupId': 'OG002'}]}]}, {'title': 'IL10', 'categories': [{'measurements': [{'value': '26069', 'spread': '6793', 'groupId': 'OG000'}, {'value': '17528', 'spread': '9660', 'groupId': 'OG001'}, {'value': '2300', 'spread': '2230', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For IL10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Ordinary one-way ANOVA Bartlett's test"}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations.", 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'FG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '3 participants were consented but never started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Digoxin 3 mcg/Kg/Day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day\n\nDigoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin'}, {'id': 'BG001', 'title': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day\n\nDigoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'oral placebo\n\nPlacebo: Oral placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'spread': '9', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '15', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '12', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics were only collected from completers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-19', 'size': 294072, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-31T16:22', 'hasProtocol': True}, {'date': '2022-03-25', 'size': 247912, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-13T16:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2024-04-30', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2018-06-06', 'resultsFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2018-06-06', 'dispFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-10', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'timeFrame': 'after starting digoxin', 'description': "Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached."}, {'measure': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'timeFrame': '1 week after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached."}, {'measure': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'timeFrame': '2 weeks after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached."}, {'measure': 'Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production', 'timeFrame': '3 weeks after starting digoxin', 'description': "Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached."}], 'secondaryOutcomes': [{'measure': 'Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro', 'timeFrame': '6 weeks', 'description': "Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.', 'detailedDescription': 'To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.\n\nTo investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age \\>18 y ≤ 70 years\n2. subjects with normal serum creatinine, normal EKG and currently not taking any medication.\n\nExclusion criteria\n\n1. Autoimmune liver disease (ANA \\> 1/320)\n2. Chronic viral hepatitis\n3. Hepatocellular carcinoma\n4. Complete portal vein thrombosis\n5. Extrahepatic terminal disease\n6. Pregnancy\n7. Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date\n8. Active alcohol abuse (\\>50 g/day for men and \\>40 g/day for women) in the last 3 months\n9. AST \\> ALT and total bilirubin \\> 3 mg/dl in the past 3 months\n10. Liver biopsy and/or clinical picture consistent with alcoholic hepatitis\n11. Lack of signed informed consent.\n12. Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation.\n13. Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs.'}, 'identificationModule': {'nctId': 'NCT03559868', 'briefTitle': 'Inhibition of Sterile Inflammation by Digoxin', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Inhibition of Sterile Inflammation by Digoxin', 'orgStudyIdInfo': {'id': '2000025289'}, 'secondaryIdInfos': [{'id': '1U01AA026962-01', 'link': 'https://reporter.nih.gov/quickSearch/1U01AA026962-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Digoxin 3 mcg/Kg/day', 'description': 'Patients receiving oral digoxin 3 mcg/Kg/day', 'interventionNames': ['Drug: Digoxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digoxin 0.15 mcg', 'description': 'Patients receiving oral digoxin 0.15 mcg/Kg/day', 'interventionNames': ['Drug: Digoxin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'oral placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Digoxin', 'type': 'DRUG', 'description': 'Participants will receive 3 mcg/Kg/day doses of oral digoxin', 'armGroupLabels': ['Digoxin 3 mcg/Kg/day']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Participants will receive 0.15 mcg/Kg/day doses of oral digoxin', 'armGroupLabels': ['Digoxin 0.15 mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Centre of Clinical Investigation', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Wajahat Mehal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}