RecruitingNCT07621458

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

Impact of the Revised Aldosterone-Renin Ratio (ARR) Cutoff in the 2025 Primary Aldosteronism Guideline in Real-World Practice: A Prospective Study

Sponsor

Seoul National University Hospital

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Primary Aldosteronism

Summary

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

Min Age: 18 Years

Inclusion Criteria7

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)
Aldosterone-to-renin ratio (ARR) >20 by immunoassay or >15 by LC-MS/MS
Participants meeting criteria for intermediate probability of lateralizing primary aldosteronism
For participants with ARR values between 20 and 30, repeat ARR measurement within 26 weeks demonstrating persistent ARR >20

Exclusion Criteria8

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
Current use of combined estrogen- and progesterone-containing oral contraceptive pills or hormone replacement therapy
High probability primary aldosteronism defined as hypokalemia with PRA <0.2 ng/mL/hr and PAC >20 ng/dL by immunoassay or >15 ng/dL by LC-MS/MS
Low probability primary aldosteronism defined as PAC <11 ng/dL by immunoassay or <8 ng/dL by LC-MS/MS
Inability to undergo saline infusion test according to investigator judgment