Cutoff revision effects and NNT in primary aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study examines real-world outcomes after applying a revised aldosterone-to-renin ratio cutoff (>20) for PA screening. Participants with hypertension and intermediate PA probability undergo standardized ARR testing after protocol-based medication adjustment, followed by confirmatory saline infusion testing. The study will determine the number needed to test to diagnose PA, identify the optimal ARR cutoff for Korean patients, and measure biochemical treatment response at 6 months after confirmed PA management. Secondary goals include assessing screening efficiency and diagnostic yield in routine clinical practice. The project operates under institutional guidelines across collaborating centers in Seoul, Korea, with standard PA management applied where PA is confirmed.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Hospital
  Seoul, Korea, Republic of, South Korea Recruiting

Study contacts

• Study coordinator: Yun Mi Choi
• Email: ymchoi@hallym.or.kr
• Phone: +82-31-8086-3655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.