Optimizing Diagnosis Of Primary Aldosteronism

NCT02755519 | Completed DMC

• 1 other identifier: ODPA 2016
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To optimize the confirmatory tests for primary aldosteronism.

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism; confirmatory test; hypertension

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (1)

• Incidence of cardiovascular diseases in Primary Aldosteronism

  3 years

Study Arms (2)

Primary Aldosteronism

1. Those with hypertension, and with or without hypoglycemia; 2. Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1

Non-Primary Aldosteronism

1. Those with Primary Hypertension; 2. Those with adrenal diseases except for Primary Aldosteronism

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• With hypertension;
• With adrenal diseases

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (6)

• 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.

  PMID: 17563566 BACKGROUND

• 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.

  PMID: 24762111 BACKGROUND

• 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.

  PMID: 26565948 BACKGROUND

• 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.

  PMID: 22419718 BACKGROUND

• 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.

  PMID: 16728547 BACKGROUND

• 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.

  PMID: 11408392 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qifu Li, M.D., PhD.

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

CN (1)