Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

NCT03500120 | Completed

• 1 other identifier: DASSSTPA 2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was undertaken prospectively to compare the diagnostic significance of the seated saline suppression testing (SSST) with the captopril challenge testing (CCT) in hypertensive patients with suspected primary aldosteronism (PA) using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.

Conditions

Primary Aldosteronism

Keywords

Saline suppression testing, Seated, Recumbent

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Seated Saline Suppression Test

  compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard

  2 weeks

Secondary Outcomes (1)

• The cutoff of SSST for diagnosis of PA

  2 weeks

Study Arms (2)

Primary Aldosteronism

Aldosterone/renin concentration ratio(ARR)≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST≥6 ng/dl

Diagnostic Test: Seated saline infusion test

non Primary Aldosteronism

1\. ARR≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST\<6 ng/dl

Diagnostic Test: Seated saline infusion test

Interventions

Seated saline infusion test DIAGNOSTIC_TEST

Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements. Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge.

Also known as: Captopril challenge test, Fludrocortisone suppression test

Primary Aldosteronism; 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: Non-Probability Sample

Study Population

Hospital or clinic patients with hypertension in a single tertiary hospital center.

You may qualify if:

• patients with Joint National Commission stage 2 (\>160-179/100-109mm Hg), stage 3 (\>180/110 mmHg), or drug-resistant hypertension;
• hypertension and spontaneous or diuretic-induced hypokalemia;
• hypertension with adrenal incidentaloma;
• hypertension and a family history of early-onset hypertension;
• cerebrovascular accident at a young age (\<40 years);
• all hypertensive first-degree relatives of patients with PA.

You may not qualify if:

• heart failure;
• chronic kidney disease with an estimated Glomerular Filtration Rate \<30 ml/min/1.73 m2;
• liver cirrhosis;
• terminal malignant tumor;
• current use of steroids or oral contraceptives;
• pregnancy or lactation.

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)

• 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 BACKGROUND

• Reznik Y, Amar L, Tabarin A. SFE/SFHTA/AFCE consensus on primary aldosteronism, part 3: Confirmatory testing. Ann Endocrinol (Paris). 2016 Jul;77(3):202-7. doi: 10.1016/j.ando.2016.01.007. Epub 2016 Jun 16.

  PMID: 27318644 BACKGROUND

• 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

• Mulatero P, Dluhy RG, Giacchetti G, Boscaro M, Veglio F, Stewart PM. Diagnosis of primary aldosteronism: from screening to subtype differentiation. Trends Endocrinol Metab. 2005 Apr;16(3):114-9. doi: 10.1016/j.tem.2005.02.007.

  PMID: 15808809 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

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and complete blood cell. Application: 1. diagnosis of PA and primary hypertension; 2.differential diagnosis of PA;

MeSH Terms

Conditions

Hyperaldosteronism; Pressure Ulcer

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qifu Li, PHD

  the Chongqing Primary Aldosteronism Study (CONPASS) Group

  STUDY CHAIR

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 9, 2018
• First Posted: April 17, 2018
• Study Start: September 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 27, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)