Study on Cutoff Revision Effects and Evaluation of NNT in Primary Aldosteronism

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeoul National University Hospital

About this trial

The goal of this observational study is to evaluate the real-world impact of applying the revised aldosterone-to-renin ratio (ARR) cutoff recommended in the 2025 primary aldosteronism guideline in adults with hypertension and biochemical findings suggestive of an intermediate probability of lateralizing primary aldosteronism (PA). The main questions it aims to answer are:

* What is the number needed to test (NNT) to diagnose one case of primary aldosteronism when using the revised ARR cutoff (\>20)? * What is the optimal ARR cutoff for diagnosing PA in Korean patients? * What is the biochemical treatment response rate at 6 months after treatment for confirmed PA?

Participants will:

* Undergo standardized ARR testing after protocol-based medication adjustment and controlled sampling conditions. * Undergo confirmatory testing using the saline infusion test (SIT). * Receive standard clinical management for confirmed PA according to institutional practice. * Be followed for assessment of biochemical outcomes after treatment.

Eligibility criteria

Qualifiers

Adults aged 18 years or older

Diagnosis of hypertension or current use of antihypertensive medications

Plasma renin activity (PRA) ≤1 ng/mL/hr

Plasma aldosterone concentration (PAC) ≥10 ng/dL by immunoassay or ≥7.5 ng/dL by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Disqualifiers

Current use of mineralocorticoid receptor antagonists or amiloride that cannot be discontinued according to study protocol

Previous adrenalectomy

Chronic kidney disease stage 4 or higher (estimated glomerular filtration rate <30 mL/min/1.73 m²)

Pregnancy

Trial design

Treatments tested in this trial

  • Saline Infusion Test

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

Gangneung Asan Hospital

Collaborator

Nowon Eulji Medical Center

Collaborator

Inha University Hospital

Collaborator

Asan Medical Center

Collaborator

Samsung Medical Center

Collaborator

Eunpyeong St. Mary's Hospital

Collaborator

Chungnam National University Hospital

Collaborator

Kangbuk Samsung Hospital

Collaborator

Ajou University School of Medicine

Collaborator

Hallym University Dongtan Sacred Heart Hospital

Collaborator

DongGuk University

Collaborator

Korea University Guro Hospital

Collaborator

Chonnam National University Hospital

Collaborator