Chongqing Primary Aldosteronism Study

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ClinicalTrials.gov Identifier: NCT03224312

Recruitment Status : Active, not recruiting

First Posted : July 21, 2017

Last Update Posted : January 31, 2019

Sponsor:

Information provided by (Responsible Party):

Qifu Li, First Affiliated Hospital of Chongqing Medical University

Study Description

Brief Summary:

We aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.

Condition or disease	Intervention/treatment
Primary Aldosteronism	Other: no intervention

Detailed Description:

Primary aldosteronism (PA) is caused by adrenocortical lesions characterized with autonomous secretion of aldosterone. It is a common cause of secondary hypertension and its reported prevalence ranges from 5% to 20% in hypertensive patients. Several studies have provided evidence that patients with PA are especially prone to cardiovascular and renal complications, stroke and fibrosis of arteries in PA in comparison with essential hypertension. Unilateral PA is generally treated by adrenalectomy and idiopathic bilateral adrenal hyperplasia is treated with the mineralocorticoid antagonist. However, aldosterone excess may be typically long-standing, and the proinflammatory effects of aldosterone may have led to irreversible damage to the vascular wall, the myocardium, and the kidney, increasing long-term mortality despite initiation of specific treatment. A study demonstrated that either treatment reduced excess renal and cardiovascular morbidity to a level similar to that of matched essential hypertensives. However, no prospective study has so far investigated the risk of cardiovascular and cerebrovascular events and long-term mortality in Chinese PA patients. In this study, we aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.

Study Design

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Study Type :	Observational
Estimated Enrollment :	1500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Chongqing Primary Aldosteronism Study
Actual Study Start Date :	October 1, 2016
Estimated Primary Completion Date :	December 31, 2027
Estimated Study Completion Date :	December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial hyperaldosteronism

Genetic and Rare Diseases Information Center resources: Hyperadrenalism

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Primary aldosteronism	Other: no intervention no intervention
Essential hypertension	Other: no intervention no intervention

Outcome Measures

Primary Outcome Measures :

numbers of patients who develop cardiovascular events [ Time Frame: 5 years ]
compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension

Secondary Outcome Measures :

estimated glomerular filtration rate (eGFR) [ Time Frame: 5 years ]
Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)
The incidence of new atrial fibrillation [ Time Frame: 5 years ]
Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension
The incidence of left ventricular hypertrophy [ Time Frame: 5 years ]
Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension
the variation of carotid intima-media thickness [ Time Frame: 5 years ]
Compare the occurrence of the variation of carotid intima-media thickness between patients with primary aldosteronism and essential hypertension
subgroup analysis of cardiovascular events [ Time Frame: 5 years ]
Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia
quality of life score [ Time Frame: 5 years ]
Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.
Cardiovascular risk score [ Time Frame: 5 years ]
To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA

Biospecimen Retention: Samples With DNA

Serum, plasma and complete blood cell.

Application:

diagnosis of PA and primary hypertension;
differential diagnosis of PA;
finding risk factors of CVD in PA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

In this study, we aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.

Criteria

Inclusion Criteria:

Diagnosis of hypertension, or previously diagnosed Primary Aldosteronism;
Aged between 18-80 year, gender is not limited;
Voluntary to sign on the informed consent.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224312

Locations

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China, Chongqing
Qifu Li
Chongqing, Chongqing, China, 400016

Sponsors and Collaborators

Chongqing Medical University

Investigators

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Study Chair:	Qifu Li, phD	First Affiliated Hospital of Chongqing Medical University

More Information

Publications:

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.

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.

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: dgaa634. doi: 10.1210/clinem/dgaa634.

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). pii: dgaa282. doi: 10.1210/clinem/dgaa282.

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Responsible Party:	Qifu Li, Director of endocrinology, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:	NCT03224312
Other Study ID Numbers:	CONPASS
First Posted:	July 21, 2017 Key Record Dates
Last Update Posted:	January 31, 2019
Last Verified:	January 2019

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Qifu Li, First Affiliated Hospital of Chongqing Medical University:


Primary aldosteronism cardiovascular events cerebrovascular events

Additional relevant MeSH terms:

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Hyperaldosteronism Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases

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