Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-03-08 @ 11:20 PM
Study NCT ID:
NCT03224312
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chongqing Primary Aldosteronism Study
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_WITH_DNA', 'description': 'Serum, plasma and complete blood cell, adrenals.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of patients who develop cardiovascular events', 'timeFrame': '1-15 years', 'description': 'compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension'}], 'secondaryOutcomes': [{'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': '1-15 years', 'description': 'Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)'}, {'measure': 'The incidence of new atrial fibrillation', 'timeFrame': '1-15 years', 'description': 'Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension'}, {'measure': 'The incidence of left ventricular hypertrophy', 'timeFrame': '1-15 years', 'description': 'Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension'}, {'measure': 'the variation of carotid intima-media thickness', 'timeFrame': '1-15 years', 'description': 'Compare the occurrence of the variation of carotid intima-media thickness between patients with primary aldosteronism and essential hypertension'}, {'measure': 'subgroup analysis of cardiovascular events', 'timeFrame': '1-15 years', 'description': 'Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia'}, {'measure': 'quality of life score', 'timeFrame': '1-15 years', 'description': 'Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.'}, {'measure': 'Cardiovascular risk score', 'timeFrame': '1-15 years', 'description': 'To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary aldosteronism', 'cardiovascular events', 'cerebrovascular events'], 'conditions': ['Primary Aldosteronism']}, 'referencesModule': {'references': [{'pmid': '28576687', 'type': 'BACKGROUND', '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': '28385310', 'type': 'BACKGROUND', 'citation': 'Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.'}, {'pmid': '27535640', 'type': 'BACKGROUND', 'citation': 'Stowasser M, Gordon RD. Primary Aldosteronism: Changing Definitions and New Concepts of Physiology and Pathophysiology Both Inside and Outside the Kidney. Physiol Rev. 2016 Oct;96(4):1327-84. doi: 10.1152/physrev.00026.2015.'}, {'pmid': '38270079', 'type': 'DERIVED', 'citation': 'He C, Li R, Yang J, Shen H, Wang Y, Chen X, Luo W, Zeng Q, Ma L, Song Y, Cheng Q, Wang Z, Wu FF, Li Q, Yang S, Hu J. Optimizing the aldosterone-to-renin ratio cut-off for screening primary aldosteronism based on cardiovascular risk: a collaborative study. Clin Exp Hypertens. 2024 Dec 31;46(1):2301571. doi: 10.1080/10641963.2023.2301571. Epub 2024 Jan 25.'}, {'pmid': '32898224', 'type': 'DERIVED', 'citation': 'Yang Y, Williams TA, Song Y, Yang S, He W, Wang K, Cheng Q, Ma L, Luo T, Yang J, Reincke M, Burrello J, Li Q, Mulatero P, Hu J. Nomogram-Based Preoperative Score for Predicting Clinical Outcome in Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa634. doi: 10.1210/clinem/dgaa634.'}, {'pmid': '32449927', 'type': 'DERIVED', 'citation': 'Wang K, Hu J, Yang J, Song Y, Fuller PJ, Hashimura H, He W, Feng Z, Cheng Q, Du Z, Wang Z, Ma L, Yang S, Li Q. Development and Validation of Criteria for Sparing Confirmatory Tests in Diagnosing Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa282. doi: 10.1210/clinem/dgaa282.'}]}, 'descriptionModule': {'briefSummary': 'We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.', 'detailedDescription': 'This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hypertensive patients who completed ARR screening and necessary further tests and Voluntary to be followed up will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. hypertensive patients who completed ARR screening and necessary further tests;\n2. Voluntary to sign the informed consent.\n\nExclusion Criteria:\n\n1. patients with severe cardiac, hepatic or renal dysfunction;\n2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis et al."}, 'identificationModule': {'nctId': 'NCT03224312', 'briefTitle': 'Chongqing Primary Aldosteronism Study', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Chongqing Primary Aldosteronism Study', 'orgStudyIdInfo': {'id': 'CONPASS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary aldosteronism', 'description': 'screened, confirmed and subtyped according to the guidelines.', 'interventionNames': ['Other: no intervention']}, {'label': 'Essential hypertension', 'description': 'screened for PA and excluded the diagnosis of PA as well as other secondary hypertesion', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Essential hypertension', 'Primary aldosteronism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qifu Li, PhD', 'role': 'CONTACT', 'email': 'liqifu@yeah.net', 'phone': '+86 23 89011552'}], 'facility': 'Qifu Li', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Qifu Li, phD', 'role': 'CONTACT', 'email': 'liqifu@yeah.net', 'phone': '+86 023-89011552'}, {'name': 'Shumin Yang, phD', 'role': 'CONTACT', 'email': '443068494@qq.com', 'phone': '+86 023-89011552'}], 'overallOfficials': [{'name': 'Qifu Li, phD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of endocrinology', 'investigatorFullName': 'Qifu Li', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}