Clinical trial NCT03224312: Chongqing Primary Aldosteronism Study
Official title: Chongqing Primary Aldosteronism Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Keywords: Primary aldosteronism
cardiovascular events
cerebrovascular events
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hypertensive patients who completed ARR screening and necessary further tests and Voluntary to be followed up will be included.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. hypertensive patients who completed ARR screening and necessary further tests;
2. Voluntary to sign the informed consent.

Exclusion Criteria:

1. patients with severe cardiac, hepatic or renal dysfunction;
2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis et al.

Primary outcomes:
measure: numbers of patients who develop cardiovascular events
timeFrame: 1-15 years
Secondary outcomes:
measure: estimated glomerular filtration rate (eGFR)
timeFrame: 1-15 years
measure: The incidence of new atrial fibrillation
timeFrame: 1-15 years
measure: The incidence of left ventricular hypertrophy
timeFrame: 1-15 years
measure: the variation of carotid intima-media thickness
timeFrame: 1-15 years
measure: subgroup analysis of cardiovascular events
timeFrame: 1-15 years
measure: quality of life score
timeFrame: 1-15 years
measure: Cardiovascular risk score
timeFrame: 1-15 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qifu Li
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, phD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.