Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-30 @ 10:06 PM
Study NCT ID:
NCT00874432
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D017706', 'term': 'Lisinopril'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'axd@medicine.wisc.edu', 'phone': '(608) 262-9306', 'title': 'Dr. Arjang Djamali', 'organization': 'University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There is limited data for this study, the PI is now in private practice and some raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.'}}, 'adverseEventsModule': {'timeFrame': 'up to 12 months', 'description': 'There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor\n\nlisinopril: 1 x 40 mg per day', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chronic Kidney Disease', 'description': 'angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Age Matched Control-ACE-I', 'description': 'ace-inhibitor\n\nlisinopril: 1 x 40 mg per day', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Age Matched Control', 'description': 'Placebo\n\nangiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Uticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip Parasthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiff Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aortic Pulse Wave Velocity (PWV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease', 'description': 'Participants over age 60 with Chronic Kidney Disease (CKD)'}, {'id': 'OG001', 'title': 'Age Matched Control', 'description': 'Healthy age-matched control over age 60'}], 'classes': [{'title': 'Carotid-Femoral Pulse Wave Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.90', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '9.96', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Carotid-Brachial Pulse Wave Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.62', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Carotid-Radial Pulse Wave Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.03', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '8.38', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'p-value for CBPWV between CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.739', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'p-value for CRPWV between CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.471', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'p-value for CFPWV between CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 months', 'description': 'PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of the baseline pulse wave velocity measures between the two groups (CKD vs no CKD) prior to intervention with ACE inhibitor. Data analyzed is from 32 participants due to drop out either from study self withdrawal (3) or ineligibility (1 = BP too low to start medication) and 7 without adequate testing data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Vascular Stiffness As Measured by PWV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease', 'description': 'angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}, {'id': 'OG002', 'title': 'Age Matched Control-ACE-I', 'description': 'ace-inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'OG003', 'title': 'Age Matched Control', 'description': 'Placebo\n\nangiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}], 'classes': [{'title': 'CBPWV Baseline', 'categories': [{'measurements': [{'value': '7.87', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '6.28', 'spread': 'NA', 'comment': 'only one measurement', 'groupId': 'OG001'}, {'value': '9.14', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '8.17', 'spread': '1.61', 'groupId': 'OG003'}]}]}, {'title': 'CBPWV 12 months', 'categories': [{'measurements': [{'value': '8.40', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '8.28', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '8.65', 'spread': '1.87', 'groupId': 'OG002'}, {'value': '8.06', 'spread': '2.02', 'groupId': 'OG003'}]}]}, {'title': 'CRPWV Baseline', 'categories': [{'measurements': [{'value': '9.03', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '4.80', 'spread': 'NA', 'comment': 'only one measurement', 'groupId': 'OG001'}, {'value': '9.75', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '8.95', 'spread': '1.69', 'groupId': 'OG003'}]}]}, {'title': 'CRPWV 12 months', 'categories': [{'measurements': [{'value': '8.57', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '8.66', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '8.16', 'spread': '1.93', 'groupId': 'OG002'}, {'value': '9.43', 'spread': '1.71', 'groupId': 'OG003'}]}]}, {'title': 'CFPWV Baseline', 'categories': [{'measurements': [{'value': '10.20', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '7.95', 'spread': 'NA', 'comment': 'only one measurement', 'groupId': 'OG001'}, {'value': '9.96', 'spread': '2.52', 'groupId': 'OG002'}, {'value': '9.55', 'spread': '2.64', 'groupId': 'OG003'}]}]}, {'title': 'CFPWV 12 months', 'categories': [{'measurements': [{'value': '11.07', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '10.66', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '8.33', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '9.79', 'spread': '1.97', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the baseline CBPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.869', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the 12 month CBPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.709', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the baseline CRPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.340', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the 12 month CBPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.730', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the baseline CFPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.204', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This p-value compares the 12 month CFPWV measures for the CKD vs Controls group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.963', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'This compares the 12 month CBPWV measure of ACE-I CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'This compares the 12 month CRPWV measure of ACE-I CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.176', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'This compares the 12 month CFPWV measure of ACE-I CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.402', 'groupIds': ['OG000'], 'groupDescription': 'This compares the baseline and 12 month CBPWV measure of the ACE-I CKD', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.586', 'groupIds': ['OG000'], 'groupDescription': 'This compares the baseline and 12 month CRPWV measure of the ACE-I CKD', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.455', 'groupIds': ['OG000'], 'groupDescription': 'This compares the baseline and 12 month CFPWV measure of the ACE-I CKD', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.418', 'groupIds': ['OG002'], 'groupDescription': 'This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.091', 'groupIds': ['OG002'], 'groupDescription': 'This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.034', 'groupIds': ['OG002'], 'groupDescription': 'This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.921', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This compares the 12 month CBPWV measure of the CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.887', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This compares the 12 month CRPWV measure of the CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.759', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'This compares the 12 month CFPWV measure of the CKD and Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.851', 'groupIds': ['OG003'], 'groupDescription': 'This compares the baseline and 12 month CBPWV measure of the Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.733', 'groupIds': ['OG003'], 'groupDescription': 'This compares the baseline and 12 month CRPWV measure of the Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.902', 'groupIds': ['OG003'], 'groupDescription': 'This compares the baseline and 12 month CFPWV measure of the Control groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.414', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.942', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.990', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.273', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.516', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.102', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'Comparison between Participants with Stage 3 Chronic Kidney Disease (CKD) and age matched Controls without CKD. The numbers reported are the mean of all the participants in the group at two points in time - the baseline and at 12 months for CFPWV, CBPWV, and CRPWV.\n\nCarotid-Femoral Pulse Wave Velocity (CFPWV) Carotid-Brachial Pulse Wave Velocity (CBPWV) Carotid-Radial Pulse Wave Velocity (CRPWV)', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each arm that had measurements for both baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure From Baseline to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease', 'description': 'angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}, {'id': 'OG002', 'title': 'Age Matched Control-ACE-I', 'description': 'ace-inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'OG003', 'title': 'Age Matched Control', 'description': 'Placebo\n\nangiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}], 'timeFrame': 'up to 12 months', 'description': 'Change in Blood Pressure will be used to measure the effect of ACE-inhibitors on the clinical markers of Cardiovascular Disease in participants with stage 3 CKD.', 'reportingStatus': 'POSTED', 'populationDescription': 'There is limited data for this study, the PI is now in private practice and the raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'FG001', 'title': 'Chronic Kidney Disease', 'description': 'angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}, {'id': 'FG002', 'title': 'Age Matched Control-ACE-I', 'description': 'ace-inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'FG003', 'title': 'Age Matched Control', 'description': 'Placebo\n\nangiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment occurred between January 2009 and May 2009. Patients were told about this study from the nephrologist or study coordinator around the time of their usual kidney clinic visit. Controls were enrolled through a group on campus who connects volunteers with research studies.', 'preAssignmentDetails': 'There is limited data for this study, the PI is now in private practice and some raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'BG001', 'title': 'Chronic Kidney Disease', 'description': 'angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}, {'id': 'BG002', 'title': 'Age Matched Control-ACE-I', 'description': 'ace-inhibitor\n\nlisinopril: 1 x 40 mg per day'}, {'id': 'BG003', 'title': 'Age Matched Control', 'description': 'Placebo\n\nangiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '68'}, {'value': '87', 'groupId': 'BG001', 'lowerLimit': '74', 'upperLimit': '90'}, {'value': '63.4', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '75'}, {'value': '67.3', 'groupId': 'BG003', 'lowerLimit': '62', 'upperLimit': '79'}, {'value': '68', 'groupId': 'BG004', 'lowerLimit': '61', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Serum Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'data no longer exists', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'data no longer exists', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'unable to calculate', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Only data for Aim 1 of this study has been located.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2009-04-01', 'resultsFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aortic Pulse Wave Velocity (PWV)', 'timeFrame': 'up to 12 months', 'description': 'PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.'}], 'secondaryOutcomes': [{'measure': 'Mean Vascular Stiffness As Measured by PWV', 'timeFrame': 'baseline and 12 months', 'description': 'Comparison between Participants with Stage 3 Chronic Kidney Disease (CKD) and age matched Controls without CKD. The numbers reported are the mean of all the participants in the group at two points in time - the baseline and at 12 months for CFPWV, CBPWV, and CRPWV.\n\nCarotid-Femoral Pulse Wave Velocity (CFPWV) Carotid-Brachial Pulse Wave Velocity (CBPWV) Carotid-Radial Pulse Wave Velocity (CRPWV)'}, {'measure': 'Change in Blood Pressure From Baseline to 12 Months', 'timeFrame': 'up to 12 months', 'description': 'Change in Blood Pressure will be used to measure the effect of ACE-inhibitors on the clinical markers of Cardiovascular Disease in participants with stage 3 CKD.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular disease', 'angiotensin converting enzyme inhibitors', 'chronic kidney disease', 'cardiovascular disease in elderly patients with CKD'], 'conditions': ['Cardiovascular Disease', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '17976426', 'type': 'BACKGROUND', 'citation': 'Ryan TP, Sloand JA, Winters PC, Corsetti JP, Fisher SG. Chronic kidney disease prevalence and rate of diagnosis. Am J Med. 2007 Nov;120(11):981-6. doi: 10.1016/j.amjmed.2007.05.012.'}, {'pmid': '9831236', 'type': 'BACKGROUND', 'citation': 'Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45.'}, {'pmid': '11641313', 'type': 'BACKGROUND', 'citation': 'Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.'}, {'pmid': '16245242', 'type': 'BACKGROUND', 'citation': 'Covic A, Haydar AA, Bhamra-Ariza P, Gusbeth-Tatomir P, Goldsmith DJ. Aortic pulse wave velocity and arterial wave reflections predict the extent and severity of coronary artery disease in chronic kidney disease patients. J Nephrol. 2005 Jul-Aug;18(4):388-96.'}, {'pmid': '15216492', 'type': 'BACKGROUND', 'citation': 'London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. doi: 10.1053/j.arrt.2004.02.008.'}, {'pmid': '15754271', 'type': 'BACKGROUND', 'citation': 'Wang MC, Tsai WC, Chen JY, Huang JJ. Stepwise increase in arterial stiffness corresponding with the stages of chronic kidney disease. Am J Kidney Dis. 2005 Mar;45(3):494-501. doi: 10.1053/j.ajkd.2004.11.011.'}, {'pmid': '15942250', 'type': 'BACKGROUND', 'citation': 'Kundhal K, Lok CE. Clinical epidemiology of cardiovascular disease in chronic kidney disease. Nephron Clin Pract. 2005;101(2):c47-52. doi: 10.1159/000086221. Epub 2005 Jun 7.'}, {'pmid': '16461839', 'type': 'BACKGROUND', 'citation': 'Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.'}, {'pmid': '8840292', 'type': 'BACKGROUND', 'citation': 'London GM, Guerin AP, Marchais SJ, Pannier B, Safar ME, Day M, Metivier F. Cardiac and arterial interactions in end-stage renal disease. Kidney Int. 1996 Aug;50(2):600-8. doi: 10.1038/ki.1996.355.'}, {'pmid': '14871413', 'type': 'BACKGROUND', 'citation': 'Shinohara K, Shoji T, Tsujimoto Y, Kimoto E, Tahara H, Koyama H, Emoto M, Ishimura E, Miki T, Tabata T, Nishizawa Y. Arterial stiffness in predialysis patients with uremia. Kidney Int. 2004 Mar;65(3):936-43. doi: 10.1111/j.1523-1755.2004.00468.x.'}, {'pmid': '14732732', 'type': 'BACKGROUND', 'citation': 'Safar ME, London GM, Plante GE. Arterial stiffness and kidney function. Hypertension. 2004 Feb;43(2):163-8. doi: 10.1161/01.HYP.0000114571.75762.b0. Epub 2004 Jan 19.'}, {'pmid': '15820199', 'type': 'BACKGROUND', 'citation': 'Dao HH, Essalihi R, Bouvet C, Moreau P. 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Hypertension. 1989 Apr;13(4):392-400. doi: 10.1161/01.hyp.13.4.392.'}, {'pmid': '12975261', 'type': 'BACKGROUND', 'citation': 'Mitchell GF, Lacourciere Y, Ouellet JP, Izzo JL Jr, Neutel J, Kerwin LJ, Block AJ, Pfeffer MA. Determinants of elevated pulse pressure in middle-aged and older subjects with uncomplicated systolic hypertension: the role of proximal aortic diameter and the aortic pressure-flow relationship. Circulation. 2003 Sep 30;108(13):1592-8. doi: 10.1161/01.CIR.0000093435.04334.1F. Epub 2003 Sep 15.'}, {'pmid': '15211442', 'type': 'BACKGROUND', 'citation': 'Hallan S, Asberg A, Lindberg M, Johnsen H. Validation of the Modification of Diet in Renal Disease formula for estimating GFR with special emphasis on calibration of the serum creatinine assay. Am J Kidney Dis. 2004 Jul;44(1):84-93. doi: 10.1053/j.ajkd.2004.03.027.'}, {'pmid': '15882252', 'type': 'BACKGROUND', 'citation': 'Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.'}, {'pmid': '16256881', 'type': 'BACKGROUND', 'citation': 'McEniery CM, Yasmin, Hall IR, Qasem A, Wilkinson IB, Cockcroft JR; ACCT Investigators. Normal vascular aging: differential effects on wave reflection and aortic pulse wave velocity: the Anglo-Cardiff Collaborative Trial (ACCT). J Am Coll Cardiol. 2005 Nov 1;46(9):1753-60. doi: 10.1016/j.jacc.2005.07.037. Epub 2005 Oct 10.'}, {'pmid': '12081987', 'type': 'BACKGROUND', 'citation': 'Mitchell GF, Izzo JL Jr, Lacourciere Y, Ouellet JP, Neutel J, Qian C, Kerwin LJ, Block AJ, Pfeffer MA. Omapatrilat reduces pulse pressure and proximal aortic stiffness in patients with systolic hypertension: results of the conduit hemodynamics of omapatrilat international research study. Circulation. 2002 Jun 25;105(25):2955-61. doi: 10.1161/01.cir.0000020500.77568.3c.'}, {'pmid': '10724055', 'type': 'BACKGROUND', 'citation': 'Bakris GL, Weir MR. Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine: is this a cause for concern? Arch Intern Med. 2000 Mar 13;160(5):685-93. doi: 10.1001/archinte.160.5.685.'}, {'type': 'BACKGROUND', 'citation': 'Djamali A, Sadowski E, Muehrer R, et al. Losartan Improves Renal Medullary Oxygenation and Oxidative Stress in Patients with Chronic Allograft Nephropathy. J.Am.Soc.Nephrol. 15 (Abstract Issue):SA-PO1026, 2004'}]}, 'descriptionModule': {'briefSummary': 'The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.', 'detailedDescription': 'This study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, this work has important implications for improving the overall health of this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 60 years\n* BP 120/80 or higher \\*(bps will be checked weekly first 4 weeks to ensure \\< 130/80 - IF bp remains \\> 130/80 we will administer other bp meds per JNC VII guidelines)\n* CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group\n\nExclusion Criteria:\n\n* Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).\n* Serum potassium \\> 5.2 meq/L\n* Known allergy or hypersensitivity to ACE inhibitor or ARB\n* Female of childbearing age not practicing contraception\n* Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)\n* History of ACE-I induced angioedema\n* History of angioedema, hereditary or idiopathic\n* Persons lacking consent capacity\n\n * 500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios'}, 'identificationModule': {'nctId': 'NCT00874432', 'briefTitle': 'Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'H-2008-0221'}, 'secondaryIdInfos': [{'id': 'A534280', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/NEPHROLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic Kidney Disease-ACE-I', 'description': 'ace inhibitor', 'interventionNames': ['Drug: lisinopril']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chronic Kidney Disease', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Age matched control-ACE-I', 'description': 'ace-inhibitor', 'interventionNames': ['Drug: lisinopril']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Age matched control', 'description': 'Placebo', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitor']}], 'interventions': [{'name': 'angiotensin converting enzyme inhibitor', 'type': 'DRUG', 'otherNames': ['ACE-inhibitor'], 'description': 'Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day', 'armGroupLabels': ['Age matched control', 'Chronic Kidney Disease']}, {'name': 'lisinopril', 'type': 'DRUG', 'otherNames': ['ace inhibitor'], 'description': '1 x 40 mg per day', 'armGroupLabels': ['Age matched control-ACE-I', 'Chronic Kidney Disease-ACE-I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison Hospitals and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Arjang Djamali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin-Madison School of Medicine and Public Health'}, {'name': 'Laura Maursetter, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}