Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

January 26, 2021 updated by: Qifu Li, Chongqing Medical University

Case Detection and Confirmation, Subtype Classification of Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affilated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Chair: Qifu Li, PhD, the Chongqing Primary Aldosteronism Study (CONPASS) Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASSSTPA 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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