Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193137
• Other study ID #: OSL-study 2019
• Status: Completed
• Start date: November 30, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

Description:

This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. hypertensive patients with ARR=10(pg/ml)(uIU/ml)

2. hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically

Exclusion Criteria:

1. Pregnancy or lactation;

2. Child-bearing women refuse to take effective contraceptive measures;

3. History of malignant tumor;

4. Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months

5. NYHA III (New York Heart Association)and above

6. Hypohepatia

7. Chronic kidney disease with an estimated Glomerular Filtration Rate <30ml/min/1.73 m²

8. Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound

9. Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• Oral sodium loading test,Seated saline infusion test and Captopril challenge test
Oral sodium loading test : Patients received 6g oral sodium every day for 3 days. Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.

Locations

Country	Name	City	State
China	Qifu Li	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 Ma — View Citation

Mulatero P, Milan A, Fallo F, Regolisti G, Pizzolo F, Fardella C, Mosso L, Marafetti L, Veglio F, Maccario M. Comparison of confirmatory tests for the diagnosis of primary aldosteronism. J Clin Endocrinol Metab. 2006 Jul;91(7):2618-23. Epub 2006 May 2. — View Citation

Mulatero P, Monticone S, Burrello J, Veglio F, Williams TA, Funder J. Guidelines for primary aldosteronism: uptake by primary care physicians in Europe. J Hypertens. 2016 Nov;34(11):2253-7. doi: 10.1097/HJH.0000000000001088. — View Citation

Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. E — View Citation

Wu S, Yang J, Hu J, Song Y, He W, Yang S, Luo R, Li Q. Confirmatory tests for the diagnosis of primary aldosteronism: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2019 May;90(5):641-648. doi: 10.1111/cen.13943. Epub 2019 Feb 26. — View Citation

Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test	sensitivity, specificity and area under curve (AUC)	9 days
Secondary	the optimal cutoff value of urine aldosterone in oral sodium test	urine aldosterone	3 days