Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500120
• Other study ID #: DASSSTPA 2017
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The diagnosis of primary aldosteronism (PA) typically requires at least one confirmatory test. Four tests are commonly recommended by the Endocrine Society guideline, namely, oral sodium loading, saline infusion, fludrocortisone administration with oral sodium loading, and captopril challenge testing (CCT). Of these, fludrocortisone suppression testing (FST) has been considered the most reliable, but is cumbersome, difficult to perform, and relatively expensive, requiring hospital admission for several days. Alternative approaches to FST have included saline suppression testing (SST), Which requiring patients staying in the recumbent position for at least 1 h before and during the infusion of 2 L of 0.9% saline IV over 4 h. This approach also has the disadvantages of brings much inconvenience to the patient (such as urination or defecation, etc.). Ashraf H. et al. have reported that seated SST (SSST) is more sensitive than recumbent SST (RSST), especially for posture-responsive PA (95.8% versus 33.3%), however, in this small scale study, only 31 patients was PA and only three patients was tested negative for PA by FST. Specificity of each form of SST was unable to estimate and meaningful receiver operating characteristic (ROC) curve analyses could not be performed. Furthermore, it is lack of study in Chinese people. In addition, the investigators have previously found the CCT was as accurate as the FST and plasma aldosterone concentration (PAC) post-CCT is the best approach to interpret the results of the CCT. The present study was undertaken prospectively to compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. patients with Joint National Commission stage 2 (>160-179/100-109mm Hg), stage 3 (>180/110 mmHg), or drug-resistant hypertension;

2. hypertension and spontaneous or diuretic-induced hypokalemia;

3. hypertension with adrenal incidentaloma;

4. hypertension and a family history of early-onset hypertension;

5. cerebrovascular accident at a young age (<40 years);

6. all hypertensive first-degree relatives of patients with PA.

Exclusion Criteria:

1. heart failure;

2. chronic kidney disease with an estimated Glomerular Filtration Rate <30 ml/min/1.73 m2;

3. liver cirrhosis;

4. terminal malignant tumor;

5. current use of steroids or oral contraceptives;

6. pregnancy or lactation.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• Seated saline infusion 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.

Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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 — View 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 Ma — View Citation

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. Review. — 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

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. Epub 2011 Aug 9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The cutoff of SSST for diagnosis of PA	investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.	2 weeks