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
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