Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism
NCT ID: NCT04193137
Last Updated: 2021-08-04
Study Results
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Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-11-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Aldosteronism(PA)
plasma aldosterone /renin ratio (ARR)\>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC\>200 pg/ml，plasma renin concentration(PRC)\<2.5μIU/ml，with hypokalemia
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.
non Primary Aldosteronism
ARR\<10 pg/μIU or ARR\>10 pg/μIU and PAC post FST\<60pg/ml
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. hypertensive patients with ARR\<10(pg/ml)(uIU/ml) but suspicious of PA clinically
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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Chongqing Medical University
OTHER
Responsible Party
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Qifu Li
Primary Investigator
Principal Investigators
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Qifu Li, PhD
Role: STUDY_CHAIR
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Locations
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Qifu Li
Chongqing, Chongqing Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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OSL-study 2019
Identifier Type: -
Identifier Source: org_study_id
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