Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-02 @ 6:38 AM
Study NCT ID:
NCT05561361
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2022-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of SAAE on Vascular Endothelial Function in PA Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': '1 month after SAAE', 'description': 'Brachial artery endothelial function measured by flow-mediated dilation(FMD)'}, {'measure': 'endothelial function', 'timeFrame': '12 months after SAAE', 'description': 'Brachial artery endothelial function measured by flow-mediated dilation(FMD)'}], 'secondaryOutcomes': [{'measure': 'PAC', 'timeFrame': '1 month after SAAE', 'description': 'plasma aldosterone concentration'}, {'measure': 'PAC', 'timeFrame': '12 months after SAAE', 'description': 'plasma aldosterone concentration'}, {'measure': 'PRA', 'timeFrame': '1 month after SAAE', 'description': 'plasma renin activity'}, {'measure': 'PRA', 'timeFrame': '12 months after SAAE', 'description': 'plasma renin activity'}, {'measure': 'ARR', 'timeFrame': '1 month after SAAE', 'description': 'aldosterone-to-renin ratio'}, {'measure': 'ARR', 'timeFrame': '12 months after SAAE', 'description': 'aldosterone-to-renin ratio'}, {'measure': 'Serum potassium', 'timeFrame': '1 month after SAAE', 'description': 'Serum potassium'}, {'measure': 'Serum potassium', 'timeFrame': '12 months after SAAE', 'description': 'Serum potassium'}, {'measure': 'serum creatinine', 'timeFrame': '1 month after SAAE', 'description': 'serum creatinine'}, {'measure': 'serum creatinine', 'timeFrame': '12 months after SAAE', 'description': 'serum creatinine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary aldosteronism', 'selective adrenal artery embolization', 'vascular endothelial function'], 'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation', 'detailedDescription': "After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1)Aged 18-75 years, males and females;\n* (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging \\>130/80 mmHg throughout the day or averaging \\>135/85 mmHg during the day;\n* (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;\n* (4)Contraindications to spironolactone-free administration;\n* (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;\n* (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.\n\nExclusion Criteria:\n\n* (1)Secondary hypertension of other causes;\n* (2)Pregnant women or those who have a fertility plan in the next year;\n* (3)Glomerular filtration rate EGFR \\< 45 ml/min/1.73m\\^2;\n* (4)History of severe contrast allergy;\n* (5)Hyperkalemia;\n* (6)Patients with other serious organic diseases or life expectancy \\< 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;\n* (7)The diameter of adrenal space occupying lesions was more than 2 cm;\n* (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;\n* (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT05561361', 'briefTitle': 'The Effect of SAAE on Vascular Endothelial Function in PA Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation', 'orgStudyIdInfo': {'id': 'IIT-O-2021-032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SAAE group', 'description': 'Subjects received super selective adrenal artery embolization treatment', 'interventionNames': ['Procedure: Super selective adrenal artery embolization']}, {'label': 'Spironolactone group', 'description': 'Subjects received spironolactone treatment', 'interventionNames': ['Drug: Spironolactone']}], 'interventions': [{'name': 'Super selective adrenal artery embolization', 'type': 'PROCEDURE', 'otherNames': ['SAAE'], 'description': 'Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.', 'armGroupLabels': ['SAAE group']}, {'name': 'Spironolactone', 'type': 'DRUG', 'description': 'Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.', 'armGroupLabels': ['Spironolactone group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yifei Dong, doctorate', 'role': 'CONTACT', 'email': 'yf_dong66@126.com', 'phone': '+8613576007061'}], 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Yifei Dong, Doctorate', 'role': 'CONTACT', 'email': 'yf_dong66@126.com', 'phone': '+8613576007061'}], 'overallOfficials': [{'name': 'Yifei Dong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Nanchang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}