Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

NCT04193137 | Completed

• 1 other identifier: OSL-study 2019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism,; oral sodium loading test; captopril challenge test,; Saline infusion test

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test

  sensitivity, specificity and area under curve (AUC)

  9 days

Secondary Outcomes (1)

• the optimal cutoff value of urine aldosterone in oral sodium test

  3 days

Study Arms (2)

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

Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

non Primary Aldosteronism

ARR\<10 pg/μIU or ARR\>10 pg/μIU and PAC post FST\<60pg/ml

Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Interventions

Oral sodium loading test,Seated saline infusion test and Captopril challenge test DIAGNOSTIC_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.

Primary Aldosteronism(PA); non Primary Aldosteronism

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hypertensive patients being suspicious of PA in a single tertiary hospital center

You may qualify if:

• hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
• hypertensive patients with ARR\<10(pg/ml)(uIU/ml) but suspicious of PA clinically

You may not qualify if:

• Pregnancy or lactation;
• Child-bearing women refuse to take effective contraceptive measures;
• History of malignant tumor;
• Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
• NYHA III (New York Heart Association)and above
• Hypohepatia
• Chronic kidney disease with an estimated Glomerular Filtration Rate \<30ml/min/1.73 m²
• Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
• Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

Location

Related 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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

  PMID: 26934393 RESULT

• 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.

  PMID: 30255616 RESULT

• 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.

  PMID: 30721529 RESULT

• 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.

  PMID: 16670162 RESULT

• 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.

  PMID: 21828936 RESULT

• 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.

  PMID: 27607462 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and complete blood cell. 24-h urine, etc

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Qifu Li, PhD

  the Chongqing Primary Aldosteronism Study (CONPASS) Group

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 10, 2019
• Study Start: November 30, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)