Clinical trial NCT04193137: Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism
Official title: Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism,
oral sodium loading test
captopril challenge test,
Saline infusion test
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hypertensive patients being suspicious of PA in a single tertiary hospital center

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
timeFrame: 9 days
Secondary outcomes:
measure: the optimal cutoff value of urine aldosterone in oral sodium test
timeFrame: 3 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qifu Li
state: Chongqing
Study officials:
affiliation: the Chongqing Primary Aldosteronism Study (CONPASS) Group
name: Qifu Li, PhD
role: STUDY_CHAIR
References:
citation: 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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
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.
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.
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. doi: 10.1210/jc.2006-0078. Epub 2006 May 2.
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. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9.
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.