Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05262660
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Long-term Effect of SAAE and Medical Treatment for Primary Aldosteronism
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'In-hospital data were obtained from the electronic medical record system (EMRS) at our institution. The 1-month ,6-month,12-month, 2-year and 3-year data were obtained from out-patient follow-up records in the EMRS, which included their complaints, antihypertensive regimens, office, and 24-hr mean blood pressures, biochemical parameters (plasma renin, aldosterone, and potassium), adverse events, and adrenal computerized tomography (only at 6 months). Clinical and biochemical outcomes were assessed based on Primary Aldosteronism Surgical Outcome (PASO) criteria and were classified as complete success, partial success, or absent success.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcomes-Change from Baseline Systolic Blood Pressure', 'timeFrame': 'at 12 months', 'description': 'Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication'}, {'measure': 'Clinical outcomes-Change from Baseline Systolic Blood Pressure', 'timeFrame': 'at 24 months', 'description': 'Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication'}, {'measure': 'Clinical outcomes-Change from Baseline Systolic Blood Pressure', 'timeFrame': 'at 36 months', 'description': 'Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication'}], 'secondaryOutcomes': [{'measure': 'biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin', 'timeFrame': 'at 12 months', 'description': 'Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test'}, {'measure': 'biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin', 'timeFrame': 'at 24 months', 'description': 'Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test'}, {'measure': 'biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin', 'timeFrame': 'at 36 months', 'description': 'Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adrenal Arterial Embolization', 'mineralocorticoid receptor antagonist', 'clinical outcomes'], 'conditions': ['Primary Aldosteronism']}, 'referencesModule': {'references': [{'pmid': '32852871', 'type': 'RESULT', 'citation': 'Zhang H, Li Q, Liu X, Zhao Z, He H, Sun F, Hong Y, Zhou X, Li Y, Shen R, Bu X, Yan Z, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Adrenal artery ablation for primary aldosteronism without apparent aldosteronoma: An efficacy and safety, proof-of-principle trial. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1618-1626. doi: 10.1111/jch.13960. Epub 2020 Aug 27.'}, {'pmid': '34398686', 'type': 'RESULT', 'citation': 'Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.'}, {'pmid': '32865201', 'type': 'RESULT', 'citation': 'Vaidya A, Carey RM. Evolution of the Primary Aldosteronism Syndrome: Updating the Approach. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3771-83. doi: 10.1210/clinem/dgaa606.'}, {'pmid': '33196558', 'type': 'RESULT', 'citation': 'Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708.'}, {'pmid': '23789675', 'type': 'RESULT', 'citation': 'Fowler AM, Burda JF, Kim SK. Adrenal artery embolization: anatomy, indications, and technical considerations. AJR Am J Roentgenol. 2013 Jul;201(1):190-201. doi: 10.2214/AJR.12.9507.'}, {'pmid': '28576687', 'type': 'RESULT', 'citation': 'Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.'}, {'pmid': '27041162', 'type': 'RESULT', 'citation': 'Kometani M, Yoneda T, Demura M, Karashima S, Mori S, Oe M, Sawamura T, Okuda R, Yamagishi M, Takeda Y. The Long-term Effect of Adrenal Arterial Embolization for Unilateral Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile. Intern Med. 2016;55(7):769-73. doi: 10.2169/internalmedicine.55.5196. Epub 2016 Apr 1.'}, {'pmid': '33605538', 'type': 'RESULT', 'citation': 'Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.'}, {'pmid': '12676966', 'type': 'RESULT', 'citation': 'Hokotate H, Inoue H, Baba Y, Tsuchimochi S, Nakajo M. Aldosteronomas: experience with superselective adrenal arterial embolization in 33 cases. Radiology. 2003 May;227(2):401-6. doi: 10.1148/radiol.2272011798. Epub 2003 Apr 3.'}, {'pmid': '33384386', 'type': 'RESULT', 'citation': 'Zhou Y, Wang D, Jiang L, Ran F, Chen S, Zhou P, Wang P. Diagnostic accuracy of adrenal imaging for subtype diagnosis in primary aldosteronism: systematic review and meta-analysis. BMJ Open. 2020 Dec 31;10(12):e038489. doi: 10.1136/bmjopen-2020-038489.'}, {'pmid': '40468047', 'type': 'DERIVED', 'citation': 'Zhou Y, Liu S, Ji G, Yang C, Zhang L, Luo T, Huang F, Chen Z, Hou J, Wang P. Safety and efficacy of alcohol-mediated bilateral adrenal artery embolization in patients with idiopathic hyperaldosteronism: a 6-month follow-up of a randomized controlled trial. J Hum Hypertens. 2025 Jul;39(7):489-499. doi: 10.1038/s41371-025-01032-6. Epub 2025 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective controlled trial, we aim to determine whether superselective adrenal artery embolization is superior to medical treatment for patients with PA who refuse surgery for medication. Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.', 'detailedDescription': 'Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5%-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance because patients with PA are more susceptible to cardiovascular morbidity and mortality than primary hypertensive patients. Traditional treatments such as medication with mineralocorticoid receptor antagonists and adrenalectomy have some limitations. Over the past decade, superselective adrenal artery embolization (SAAE) has been used to treat PA, but their efficacies have not been compared with medication-controlled studies. Recent study found that SAAE is an effective and safe treatment for patients with PA. In this prospective controlled trial, we aim to determine whether this procedure is superior to medical treatment for patients with PA who refuse surgery for medication.\n\nPatients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Adrenal computed tomography will be performed in all patients. Patients willing to participate in the study also will undergo adrenal venous sampling (AVS) Serum aldosterone and renin levels are measured by chemiluminescence immunoassay. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome Criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of PA\n* They refused medication treatment due to intolerance of side effects\n* They had lateralization by adrenal venous sampling (AVS), and refused the adrenalectomy\n\nExclusion Criteria:\n\n* History of serious contrast agent allergy\n* Complication with severe liver diseases\n* History of myocardial infarction and stent implantation within the past 3 months\n* Renal insufficiency, with serum creatinine \\>176 umo/L\n* Pregnancy or lactation\n* History of participation in another clinical trial in the past 3 months\n* Any serious comorbidity'}, 'identificationModule': {'nctId': 'NCT05262660', 'briefTitle': 'The Long-term Effect of SAAE and Medical Treatment for Primary Aldosteronism', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chengdu Medical College'}, 'officialTitle': 'The Long-term Effect of Superselective Adrenal Arterial Embolization and Medical Treatment for Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile.', 'orgStudyIdInfo': {'id': 'SAAE-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SAAE group', 'description': 'Patients who were diagnosed with primary aldosteronism choice SAAE at our institution'}, {'label': 'MRA group', 'description': 'Patients who were diagnosed with primary aldosteronism choice medical treatment(mineralocorticoid receptor antagonists, MRA)) at our institution'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610500', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Yaqiong Zhou', 'role': 'CONTACT', 'email': '1273868593@qq.com', 'phone': '+8615184399329'}, {'name': 'Peijian Wang', 'role': 'CONTACT', 'email': 'wpjmed@aliyun.com', 'phone': '18980718263'}], 'facility': 'Yaqiong Zhou', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Yaqiong Zhou', 'role': 'CONTACT', 'email': '1273868593@qq.com', 'phone': '+8615184399329'}, {'name': 'Peijian Wang', 'role': 'CONTACT', 'email': 'wpjmed@aliyun.com', 'phone': '+861880718263'}], 'overallOfficials': [{'name': 'Yanqiu Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chengdu Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chengdu Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}