NCT04422756

Prospective Evaluation of Confirmatory Testing for Primary Aldosteronism

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective study (with a target recruitment of 200 participants) designed 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, using disease-specific treatment response as a reference gold standard. Subjects consenting to study participation will undergo a standardized seated saline infusion test, followed by an ultra low-dose ACTH stimulation test. All participants also receive adrenal vein sampling. Individuals who have unilateral disease and desire surgery will receive adrenalectomy (as part of routine care) and the remaining subjects will receive medical treatment with a mineralocorticoid receptor antagonist. Response to targeted treatment will be considered the reference gold standard for the establishing the diagnosis of primary aldosteronism.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-15
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2020-06-09
• Last updated: 2025-03-30

Locations

1 site across 1 country: Canada