ODPA: Optimizing Diagnosis Of Primary Aldosteronism
Study Details
Study Description
Brief Summary
To optimize the confirmatory tests for primary aldosteronism.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Aldosteronism Those with hypertension, and with or without hypoglycemia; Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1 |
|
| Non-Primary Aldosteronism Those with Primary Hypertension; Those with adrenal diseases except for Primary Aldosteronism |
Outcome Measures
Primary Outcome Measures
- Area under the receiver operating characteristic curve (AUC) for Salt loading test [1 week]
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.
- AUC for captopril challenge test [1 week]
Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
- AUC for fludrocortisone suppression test [1 week]
Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
Secondary Outcome Measures
- Incidence of cardiovascular diseases in Primary Aldosteronism [3 years]
Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke
Eligibility Criteria
Criteria
Inclusion Criteria:
-
With hypertension;
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With adrenal diseases
Exclusion Criteria:
-
Pregnant or during lactation period;
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Under 18 yr;
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BMI ≤ 19 or ≥ 35
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With Cancer medical history
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Been through cardiovascular diseases in the past 3 months;
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Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affilated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | 400016 |
Sponsors and Collaborators
- Chongqing Medical University
Investigators
- Principal Investigator: Qifu Li, M.D., PhD., First Affiliated Hospital of Chongqing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3.
- 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.
- 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.
- 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.
- 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.
- 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.
- ODPA 2016