Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT03945305
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of mean systolic blood pressure', 'timeFrame': '12-14 days', 'description': 'The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Mean systolic blood pressure level', 'timeFrame': '12-14 days', 'description': 'Mean systolic blood pressure levels during the last 3 days of treatment'}, {'measure': 'Changes of mean diastolic blood pressure', 'timeFrame': '12-14 days', 'description': 'The mean diastolic blood pressure in the last 3 days of treatment minus baseline mean diastolic blood pressure'}, {'measure': 'Mean diastolic blood pressure level', 'timeFrame': '12-14 days', 'description': 'Mean diastolic blood pressure levels during the last 3 days of treatment'}, {'measure': 'Blood pressure compliance rate', 'timeFrame': '15-28 days', 'description': 'Blood pressure compliance rates after treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Essential Hypertension, Remote Ischemic Conditioning'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.', 'detailedDescription': 'At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age≥40 years, ≤ 75 years, regardless of sex;\n2. Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;\n3. Signed and dated informed consent is obtained\n\nExclusion Criteria:\n\n1. Blood pressure ≥ 180/110mmHg;\n2. Planned adjustment of antihypertensive drugs in the next month;\n3. Severe hematologic disorders or significant coagulation abnormalities;\n4. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;\n5. Pregnant or lactating women;\n6. Severe hepatic and renal dysfunction, or ALT/AST \\>3 times upper limit of normal, or serum creatinine \\>265umol/l (\\>3mg/dl);\n7. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;\n8. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT03945305', 'briefTitle': 'Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SERIC-EH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RIC group', 'description': 'Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.', 'interventionNames': ['Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Patients are only treated with previous antihypertensive treatment.', 'interventionNames': ['Other: Previous antihypertensive treatment']}], 'interventions': [{'name': 'Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.', 'type': 'DEVICE', 'description': 'Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.', 'armGroupLabels': ['RIC group']}, {'name': 'Previous antihypertensive treatment', 'type': 'OTHER', 'description': 'Patients are only treated with previous antihypertensive treatment.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctor_yangyi@163.com'}], 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Yi Yang, MD,PhD', 'role': 'CONTACT', 'email': 'doctor_yangyi@163.com', 'phone': '0086-13756661217'}, {'name': 'Zhen-Ni Guo, MD', 'role': 'CONTACT', 'email': 'zhen1ni2@163.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associated Dean of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}