Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Aldosteronism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Aldosteronism

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

Seated saline infusion test

Intervention Type 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.

non Primary Aldosteronism

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

Seated saline infusion test

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Captopril challenge test Fludrocortisone suppression test

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No