Chongqing Primary Aldosteronism Study

NCT03224312 | Recruiting

• 1 other identifier: CONPASS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism

Keywords

Primary aldosteronism; cardiovascular events; cerebrovascular events

Outcome Measures

Primary Outcomes (1)

• numbers of patients who develop cardiovascular events

  compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension

  1-15 years

Secondary Outcomes (7)

• estimated glomerular filtration rate (eGFR)

  1-15 years

• The incidence of new atrial fibrillation

  1-15 years

• The incidence of left ventricular hypertrophy

  1-15 years

• the variation of carotid intima-media thickness

  1-15 years

• subgroup analysis of cardiovascular events

  1-15 years

Study Arms (2)

Primary aldosteronism

screened, confirmed and subtyped according to the guidelines.

Other: no intervention

Essential hypertension

screened for PA and excluded the diagnosis of PA as well as other secondary hypertesion

Other: no intervention

Interventions

no intervention OTHER

no intervention

Essential hypertension; Primary aldosteronism

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (6)

• 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: 28576687 BACKGROUND

• 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: 28385310 BACKGROUND

• 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: 27535640 BACKGROUND

• 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: 38270079 DERIVED

• 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: 32898224 DERIVED

• 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.

  PMID: 32449927 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and complete blood cell, adrenals.

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Qifu Li, phD

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Qifu Li, phD

CONTACT

+86 023-89011552; liqifu@yeah.net

Shumin Yang, phD

CONTACT

+86 023-89011552; 443068494@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of endocrinology

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (1)