Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

July 28, 2021 updated by: Qifu Li, Chongqing Medical University

Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism

To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test

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
        • Qifu Li

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hypertensive patients being suspicious of PA in a single tertiary hospital center

Description

Inclusion Criteria:

  1. hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
  2. hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. Child-bearing women refuse to take effective contraceptive measures;
  3. History of malignant tumor;
  4. Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
  5. NYHA III (New York Heart Association)and above
  6. Hypohepatia
  7. Chronic kidney disease with an estimated Glomerular Filtration Rate <30ml/min/1.73 m²
  8. Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
  9. Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Aldosteronism(PA)
plasma aldosterone /renin ratio (ARR)>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC>200 pg/ml，plasma renin concentration(PRC)<2.5μIU/ml，with hypokalemia
Diagnostic test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.

Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.

Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.
non Primary Aldosteronism
ARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml
Diagnostic test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.

Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.

Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
Time Frame: 9 days
sensitivity, specificity and area under curve (AUC)
9 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the optimal cutoff value of urine aldosterone in oral sodium test
Time Frame: 3 days
urine aldosterone
3 days

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)

November 30, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

December 8, 2019

First Submitted That Met QC Criteria

December 8, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSL-study 2019

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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