MedTrace Logo

Prospective Evaluation of Confirmatory Testing for Primary Aldosteronism

NCT04422756 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2025-03-30

No results posted yet for this study

Summary

This study is to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulation test for the diagnosis of primary aldosteronism.

Conditions

  • Primary Aldosteronism

Interventions

DIAGNOSTIC_TEST

Seated intravenous saline infusion test

The test will be conducted by infusing two litres of normal saline intravenously over 4 hours with the patient seated.Blood collection (for aldosterone, cortisol, renin, and electrolytes) will be performed at baseline and after completion of the infusion. Following infusion, plasma aldosterone levels \<140 pmol/L will be considered as "negative," levels \>280 pmol/L as "positive," and levels in between classified as indeterminate.

DIAGNOSTIC_TEST

Ultra low-dose ACTH stimulation test

The test will be performed by injecting 0.03 mcg of ACTH intravenously. Blood collection (for aldosterone, cortisol, and renin) will be performed at baseline and after 15 minutes. We expect a "positive" response to correspond with a plasma aldosterone \>2200 pmol/L and ARR \>220 pmol/L/mIU/L following stimulation.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hypertension Canada

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Alexander Leung, Asst. Prof · University of Calgary

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422756 on ClinicalTrials.gov