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Completed

NCT Number: NCT03500120

Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Captopril challenge test, Fludrocortisone suppression test

Primary outcomes

  1. Diagnostic Accuracy of Seated Saline Suppression Test

    Time frame: 2 weeks

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

Secondary outcomes

  1. The cutoff of SSST for diagnosis of PA

    Time frame: 2 weeks

    investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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