Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-02 @ 1:58 AM
Study NCT ID:
NCT05535595
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Treatment With Angiotensin Converting Enzyme Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005838', 'term': 'Genotype'}, {'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-08', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cough', 'timeFrame': '6 weeks after administration of drug'}, {'measure': 'Incidence of moderate/severe cough', 'timeFrame': '6 weeks after administration of drug'}], 'secondaryOutcomes': [{'measure': 'Incidence of any adverse events', 'timeFrame': '6 weeks after administration of drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '37602458', 'type': 'DERIVED', 'citation': 'Lee SH, Lee CJ, Kang Y, Park JM, Lee JH. A randomized trial of genotype-guided perindopril use. J Hypertens. 2023 Nov 1;41(11):1768-1774. doi: 10.1097/HJH.0000000000003536. Epub 2023 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'Angiotensin converting enzyme inhibitors (ACEI) are the first-line treatment for high blood pressure and congestive heart failure, and have excellent effects in improving the prognosis of cardiovascular diseases. However, ACEI is frequently discontinued due to its adverse reaction. The adverse reaction to ACEI is not uncommon, especially in Asians. Discontinuation of ACEI is known to increase the risk of poor prognosis of cardiovascular diseases.\n\nBiomarkers for predicting adverse reaction to ACEI have not yet been developed. Recently, genes related to adverse reaction to ACEI have been identified. This study is a randomized prospective study, in which the experimental group decides whether to administer the drug based on genetic information, and the control group decides whether to administer the drug without the information. In the experimental group, participants who are predicted to have a high risk of adverse reation to ACEI will receive angiotensin receptor blockers (ARB), and those who are predicted to have a low risk of adverse reaction will receive ACEI. Control group will receive ACEI. The frequency of adverse reaction will be investigated between control and experimental groups. In the genotyping and control groups, at least 45 and 31 will be enrolled, respectively, and after drug administration, a phone follow-up will be conducted at 3 weeks, followed by a visit at the 6th week, and the study will be terminated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 20 years of age and less than 79 years of age\n* Hypertension\n* No history of ACEI use\n\nExclusion Criteria:\n\n* Acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months\n* Decompensated heart failure\n* Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg\n* Hemoglobin A1c \\>9.0%\n* Thyroid dysfunction\n* Serum transaminase \\>2 times the upper limit of normal levels\n* Serum creatinine \\>2.0 mg/dL\n* Cancer\n* Pregnant or breast-feeding women, and women of childbearing potential\n* Patients who refused to participate'}, 'identificationModule': {'nctId': 'NCT05535595', 'briefTitle': 'Precision Treatment With Angiotensin Converting Enzyme Inhibitor', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor', 'orgStudyIdInfo': {'id': '4-2019-0916'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'This group will perform genetic study for predicting adverse reaction to ACEI. Based on the result of genetic study, participants will receive ACEI or ARB.', 'interventionNames': ['Drug: genotyping and selection of renin-angiotensin system blocker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will receive ACEI without genetic study.', 'interventionNames': ['Drug: Perindopril']}], 'interventions': [{'name': 'genotyping and selection of renin-angiotensin system blocker', 'type': 'DRUG', 'description': 'One of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants.\n\n* perindopril 4 mg/d after genotyping\n* candesartan 8 mg/d after genotyping', 'armGroupLabels': ['Experimental']}, {'name': 'Perindopril', 'type': 'DRUG', 'description': 'perindopril 4 mg/d without genotyping', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang-Hak Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Severance Hospital, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}