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

Recruitingn/aAges 18 Years - anyAllSeoul National University Hospital
NCT07621458 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 clin

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Saline Infusion Test
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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