Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 5:18 PM
Study NCT ID:
NCT06150560
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001017', 'term': 'Aortic Coarctation'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Left Ventricular (LV) Fibrosis', 'timeFrame': 'Baseline; Week 52', 'description': 'LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI).'}], 'secondaryOutcomes': [{'measure': 'Change in Exercise Capacity (peak VO2)', 'timeFrame': 'Baseline; Week 52', 'description': 'Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), during supine bike cardiopulmonary exercise test (Stress Echocardiogram).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coarctation of Aorta', 'High Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* B/S1 hypertension\n* SBP 100-139 average based on 3 office measurements.\n* Age 18 or Older\n* Previous COA Repair\n\nExclusion Criteria:\n\n* Currently on beta blocker (BB) therapy\n* Pregnancy/lactating\n* eGFR\\<30\n* Hyperkalemia (serum potassium \\>5.5mmol/L)\n* Severe Aortic or Mitral valve stenosis or regurgitation\n* Epicardial CAD diagnosis\n* Received antihypertensive medications within the past year'}, 'identificationModule': {'nctId': 'NCT06150560', 'acronym': 'VALUE', 'briefTitle': 'A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta', 'orgStudyIdInfo': {'id': '23-007629'}, 'secondaryIdInfos': [{'id': '1R01HL162830-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL162830-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan Group', 'description': 'Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.', 'interventionNames': ['Drug: Losartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine Group', 'description': 'Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.', 'interventionNames': ['Drug: Amlodipine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Cozaar'], 'description': '50mg administered orally once daily for 52 weeks.', 'armGroupLabels': ['Losartan Group']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': '5mg Amlodipine administered orally once daily for 52 weeks.', 'armGroupLabels': ['Amlodipine Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'ACHD Research Program', 'role': 'CONTACT', 'email': 'RSTACHDRESPRG@mayo.edu', 'phone': '(507) 293-2565'}, {'name': 'Alexander Egbe, MBBS, MPH', 'role': 'CONTACT', 'email': 'Egbe.Alexander@mayo.edu', 'phone': '(507) 284-2520'}, {'name': 'Alexander Egbe, MBBS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'ACHD Research Program', 'role': 'CONTACT', 'email': 'RSTACHDRESPRG@mayo.edu', 'phone': '(507) 293-2565'}, {'name': 'Alexander Egbe, MBBS, MPH', 'role': 'CONTACT', 'email': 'Egbe.Alexander@mayo.edu', 'phone': '(507) 284-2520'}], 'overallOfficials': [{'name': 'Alexander Egbe, MBBS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexander C. Egbe', 'investigatorAffiliation': 'Mayo Clinic'}}}}