Optimizing Diagnosis Of Primary Aldosteronism

Primary Aldosteronism Clinical Trial

— ODPA  

Official title:

Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755519
• Other study ID #: ODPA 2016
• Status: Completed
• Phase: N/A
• First received: April 8, 2016
• Last updated: November 10, 2016
• Start date: May 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To optimize the confirmatory tests for primary aldosteronism.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. — View 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. — View 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. — View 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. — View 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. — View Citation

Schirpenbach C, Seiler L, Maser-Gluth C, Rüdiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the receiver operating characteristic curve (AUC) for Salt loading test	Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated.	1 week	Yes
Primary	AUC for captopril challenge test	Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.	1 week	Yes
Primary	AUC for fludrocortisone suppression test	Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.	1 week	Yes
Secondary	Incidence of cardiovascular diseases in Primary Aldosteronism	Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke	3 years	Yes