Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-05 @ 5:33 AM
Study NCT ID:
NCT03219632
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2017-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).', 'timeFrame': '1 year', 'description': 'Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Hypertrophy', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '11231428', 'type': 'BACKGROUND', 'citation': 'Vakili BA, Okin PM, Devereux RB. Prognostic implications of left ventricular hypertrophy. Am Heart J. 2001 Mar;141(3):334-41. doi: 10.1067/mhj.2001.113218.'}, {'pmid': '21755036', 'type': 'BACKGROUND', 'citation': 'Katholi RE, Couri DM. Left ventricular hypertrophy: major risk factor in patients with hypertension: update and practical clinical applications. Int J Hypertens. 2011;2011:495349. doi: 10.4061/2011/495349. Epub 2011 Jun 30.'}, {'pmid': '8348686', 'type': 'BACKGROUND', 'citation': 'Sadoshima J, Izumo S. Molecular characterization of angiotensin II--induced hypertrophy of cardiac myocytes and hyperplasia of cardiac fibroblasts. Critical role of the AT1 receptor subtype. Circ Res. 1993 Sep;73(3):413-23. doi: 10.1161/01.res.73.3.413.'}, {'pmid': '12885747', 'type': 'BACKGROUND', 'citation': 'Okin PM, Devereux RB, Jern S, Kjeldsen SE, Julius S, Nieminen MS, Snapinn S, Harris KE, Aurup P, Edelman JM, Dahlof B; Losartan Intervention for Endpoint reduction in hypertension Study Investigations. Regression of electrocardiographic left ventricular hypertrophy by losartan versus atenolol: The Losartan Intervention for Endpoint reduction in Hypertension (LIFE) Study. Circulation. 2003 Aug 12;108(6):684-90. doi: 10.1161/01.CIR.0000083724.28630.C3. Epub 2003 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients', 'detailedDescription': 'Patients who were diagnosed with left ventricular hypertrophy (LVH) by ECG at the start of the study are followed up at 3-month intervals for 1 year.\n\nIncrease Fimasartan if blood pressure is not controlled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Registered 319 people considering 30% dropout rate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been treated or not treated with hypertension from 20 to 80 years of age\n* Patients with electrocardiographic left ventricular hypertrophy (In this study, we define left ventricular hypertrophy if one of the following two criteria is met)\n\n 1. RaVL+SV3 \\> 20mm(M). 16mm(F)\n 2. SV1+RV5 or RV6 \\> 35mm.\n* Patients who are taking or expecting Fimasartan\n\nExclusion Criteria:\n\n* Patients with unstable angina or myocardial infarction within 3 months\n* Patients with clinically significant severe valve disease, congenital heart disease, peripheral vascular disease, cerebrovascular disease\n* Clinically significant severe congestive heart failure patients\n* Patients with renal dialysis\n* Clinically significant renal disease patients\n* Patients with clinically significant hepatic impairment\n* Patients with a history of alcohol or substance abuse\n* Patients with hypersensitivity to angiotensin-receptor blocker\n* Patients needing angiotensin-receptor blocker drugs other than fimasartan\n* For women, pregnancy, Patients who are breastfeeding or planning to become pregnant\n* A person who is determined to be inappropriate by the Investigator\n* Patients participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT03219632', 'briefTitle': 'Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry', 'orgStudyIdInfo': {'id': 'ACADEMY'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'description': 'Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dong-Ju choi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Dong-Ju Choi', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}