At a glance
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Prospective Evaluation of Confirmatory Testing for Primary Aldosteronism
In Brief
An observational study evaluating Seated intravenous saline infusion test and Ultra low-dose ACTH stimulation test for Primary Aldosteronism. Completed, enrolled 183 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.