Clinical trial NCT02755519: Optimizing Diagnosis Of Primary Aldosteronism
Official title: Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism
confirmatory test
hypertension
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Who was diagnosed with hypertension according to JNC standard and was considered with the possibility of primary aldosteronism.

Group 2: Control Groups, one group for those without hypertension or with primary hypertension; the other group for those with adrenal diseases except for primary aldosteronism.

Brief summary: To optimize the confirmatory tests for primary aldosteronism.

Detailed description: In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.

Eligibility criteria: Inclusion Criteria:

* With hypertension;
* With adrenal diseases

Exclusion Criteria:

* Pregnant or during lactation period;
* Under 18 yr;
* BMI ≤ 19 or ≥ 35
* With Cancer medical history
* Been through cardiovascular diseases in the past 3 months;
* Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.

Primary outcomes:
measure: Area under the receiver operating characteristic curve (AUC) for Salt loading test
timeFrame: 1 week
measure: AUC for captopril challenge test
timeFrame: 1 week
measure: AUC for fludrocortisone suppression test
timeFrame: 1 week
Secondary outcomes:
measure: Incidence of cardiovascular diseases in Primary Aldosteronism
timeFrame: 3 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossi GP, Belfiore A, Bernini G, Desideri G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Montemurro D, Palumbo G, Rizzoni D, Rossi E, Semplicini A, Agabiti-Rosei E, Pessina AC, Mantero F; PAPY Study Investigators. Prospective evaluation of the saline infusion test for excluding primary aldosteronism due to aldosterone-producing adenoma. J Hypertens. 2007 Jul;25(7):1433-42. doi: 10.1097/HJH.0b013e328126856e.
citation: Ahmed AH, Cowley D, Wolley M, Gordon RD, Xu S, Taylor PJ, Stowasser M. Seated saline suppression testing for the diagnosis of primary aldosteronism: a preliminary study. J Clin Endocrinol Metab. 2014 Aug;99(8):2745-53. doi: 10.1210/jc.2014-1153. Epub 2014 Apr 24.
citation: Li Y, Liu Y, Li J, Wang X, Yu Y. Sodium Infusion Test for Diagnosis of Primary Aldosteronism in Chinese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):89-95. doi: 10.1210/jc.2015-2840. Epub 2015 Nov 13.
citation: Nanba K, Tamanaha T, Nakao K, Kawashima ST, Usui T, Tagami T, Okuno H, Shimatsu A, Suzuki T, Naruse M. Confirmatory testing in primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1688-94. doi: 10.1210/jc.2011-2504. Epub 2012 Mar 14.
citation: Schirpenbach C, Seiler L, Maser-Gluth C, Rudiger F, Nickel C, Beuschlein F, Reincke M. Confirmatory testing in normokalaemic primary aldosteronism: the value of the saline infusion test and urinary aldosterone metabolites. Eur J Endocrinol. 2006 Jun;154(6):865-73. doi: 10.1530/eje.1.02164.
citation: Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. doi: 10.1161/01.hyp.37.6.1440.