Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-01 @ 10:05 AM
Study NCT ID:
NCT03540992
Status:
UNKNOWN
Last Update Posted:
2018-05-30
First Post:
2018-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Diagnostic and Treatment Strategy for Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 780}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-28', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-28', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '3 years', 'description': 'Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails'}], 'secondaryOutcomes': [{'measure': 'Progression of CKD', 'timeFrame': '3 years', 'description': 'Start dialysis or doubling of serum creatinine'}, {'measure': 'Target organ damages', 'timeFrame': '3 years', 'description': 'Target organ damage: LVH confirmed by echocardiography or EKG; carotid femoral PWV≥ 12m/s; microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)'}, {'measure': 'Target blood pressure achievement', 'timeFrame': '3 years', 'description': 'Target blood pressure: Achievement of BP below 130/80 or 140/90 mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resistant Hypertension']}, 'referencesModule': {'references': [{'pmid': '33280228', 'type': 'DERIVED', 'citation': 'Lee CJ, Ha JH, Kim JY, Kim IC, Ryu SK, Rhee MY, Lee JH, Lee JH, Lee HY, Ihm SH, Chung JW, Choi JH, Shin J, Park S, Kario K. Office blood pressure threshold of 130/80 mmHg better predicts uncontrolled out-of-office blood pressure in apparent treatment-resistant hypertension. J Clin Hypertens (Greenwich). 2021 Mar;23(3):595-605. doi: 10.1111/jch.14113. Epub 2020 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in Koreans. This study will register patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them for three years. The prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.', 'detailedDescription': 'This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A pateint diagnosed with resistant hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20 years and older\n2. Office SBP\\>130 mmHg or office DBP \\>90 mmHg with 3 antihypertensive medications of different classes\n3. Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics\n\nExclusion Criteria:\n\n1. desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)\n2. women with pregnancy or on nursing\n3. within the first three months after transplantation\n4. acute renal allograft rejection\n5. within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke\n6. systolic heart failure (LVEF ≤40%)'}, 'identificationModule': {'nctId': 'NCT03540992', 'briefTitle': 'Development of Diagnostic and Treatment Strategy for Resistant Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Development of Diagnostic and Treatment Strategy for Resistant Hypertension', 'orgStudyIdInfo': {'id': '4-2017-1222'}}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sungha Park, MD', 'role': 'CONTACT', 'email': 'shpark0530@yuhs.ac', 'phone': '82-2-2228-8455'}], 'facility': 'Division of Cardiology Severance Cardiovascular Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sungha Park, MD', 'role': 'CONTACT', 'email': 'shpark0530@yuhs.ac', 'phone': '82-2-2228-8455'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}