Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT06941935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2025-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etiological Classification-guided Individual Intervention in Primary Hypertension
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-13', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Blood Pressure Recorded in a 1-Week Home Blood Pressure Diary', 'timeFrame': '3 months following intervention', 'description': 'Changes in blood pressure recorded (SBP/DBP) in a 1-week home blood pressure diary from baseline to 3 months.'}], 'secondaryOutcomes': [{'measure': 'Change in 24-hour Ambulatory Blood Pressure Monitoring', 'timeFrame': '1/2/3 months following intervention', 'description': 'Change in 24-hour ambulatory blood pressure monitoring (daytime, nighttime, and overall SBP/DBP) at 1/2 /3 months.'}, {'measure': 'Change in Home Blood Pressure Monitoring', 'timeFrame': '1/2 months following intervention', 'description': 'Change in home blood pressure monitoring (SBP/DBP) at 1/2months.'}, {'measure': 'Control Rate', 'timeFrame': '3 months following intervention', 'description': 'Proportion of patients achieving target blood pressure at 3 months.'}, {'measure': 'Drug adjustment times', 'timeFrame': '3 months following intervention', 'description': 'The total number of times to adjust blood pressure medication in 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Etiological Classification', 'Digital Intervention'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years.\n* Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n* signed informed consent.\n\nExclusion Criteria:\n\n* Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation).\n* Comorbidities such as diabetes, chronic kidney disease (eGFR \\< 30 mL/min/1.73m²), coronary artery disease, heart failure, or serious valvular heart disease.\n* History of stroke or myocardial infarction.\n* Pregnancy, breastfeeding, or planning to become pregnant.\n* Life expectancy \\< 1 year.\n* Participation in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT06941935', 'briefTitle': 'Etiological Classification-guided Individual Intervention in Primary Hypertension', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Etiological Classification-guided Individual Intervention in Primary Hypertension: An All-comer Registry Study', 'orgStudyIdInfo': {'id': 'GENESIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertension precision diagnosis and treatment group', 'description': 'participants will undergo etiological testing for primary hypertension, followed by tailored pharmacological treatment and digital blood pressure monitoring, with regular medication adjustments.', 'interventionNames': ['Other: Etiological Classification and Digital Intervention']}], 'interventions': [{'name': 'Etiological Classification and Digital Intervention', 'type': 'OTHER', 'description': "Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.", 'armGroupLabels': ['Hypertension precision diagnosis and treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Haonan Li', 'role': 'CONTACT', 'email': '2311167@tongji.edu.cn', 'phone': '+8618829895009'}], 'facility': "Department of Cardiology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yi Zhang', 'role': 'CONTACT', 'email': 'yizshcn@gmail.com', 'phone': '18917686332'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of Medicine', 'investigatorFullName': 'Ya-Wei Xu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}