An observational study in Primary Aldosteronism, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Seoul National University Hospital · Observational
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:
Participants will:
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension and is associated with an increased risk of cardiovascular, renal, and metabolic complications independent of blood pressure levels. Despite its clinical importance and the availability of effective targeted treatments such as adrenalectomy or mineralocorticoid receptor antagonists, PA remains substantially underdiagnosed in routine clinical practice, with estimates suggesting that only a small proportion of eligible hypertensive patients undergo appropriate screening.
The aldosterone-to-renin ratio (ARR) is the most widely used screening tool for PA. Traditionally, an ARR cutoff of >30 has been used to define a positive screening result. However, recent evidence suggests that this threshold may lack sufficient sensitivity and may miss a considerable number of patients with clinically relevant PA. In response, recent international hypertension and endocrine society guidelines have proposed lowering the ARR cutoff to >20 in order to improve case detection and broaden screening indications.
However, lowering the ARR threshold may also increase the number of false-positive results, potentially leading to an increased burden of aldosterone suppression test. Therefore, the clinical utility of the revised cutoff must be evaluated in real-world settings, particularly with regard to diagnostic yield and testing efficiency.
This study is a multicenter, prospective observational cohort study designed to evaluate the impact of applying the revised ARR cutoff (>20) in routine clinical practice in Korea. Patients with hypertension who meet predefined biochemical screening criteria indicating an intermediate probability of lateralizing PA will be enrolled.
Participants will undergo standardized pre-analytical preparation, including medication adjustment and controlled sampling conditions. All eligible participants will undergo confirmatory testing using the saline infusion test (SIT), performed under standardized protocols (supine or seated depending on institutional practice).
The primary objective of this study is to determine the number of confirmatory tests required to diagnose one case of PA (number needed to test, NNT) when using the revised ARR cutoff (>20). Secondary outcomes include biochemical treatment response at 6 months (complete biochemical success), and identification of an optimal ARR cutoff value using receiver operating characteristic (ROC) analysis.
The findings of this study are expected to provide real-world evidence regarding the diagnostic efficiency and clinical implications of lowering the ARR cutoff in Korean patients, and may inform future guideline updates and clinical decision-making strategies for the screening and diagnosis of primary aldosteronism.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
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Adults with hypertension who have an aldosterone-to-renin ratio (ARR) >20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with hypertension who have an aldosterone-to-renin ratio (ARR) \>20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Diagnostic Test: Saline Infusion Test
Standardized saline infusion test performed for confirmatory diagnosis of primary aldosteronism.
Number Needed to Test for Diagnosis of Primary Aldosteronism
Number of saline infusion tests required to confirm one case of primary aldosteronism among participants meeting the revised aldosterone-to-renin ratio screening cutoff criteria.
Time frame: Through study completion, an average of 6 months
Complete Biochemical Success After Treatment
Proportion of participants with confirmed primary aldosteronism who achieve complete biochemical success after treatment.
Time frame: Through study completion, an average of 6 months
Optimal Aldosterone-to-Renin Ratio Cutoff for Diagnosis of Primary Aldosteronism
Diagnostic performance and optimal cutoff value of aldosterone-to-renin ratio for identifying confirmed primary aldosteronism using receiver operating characteristic (ROC) analysis.
Time frame: Through study completion, an average of 6 months
Adrenal Vein Sampling Lateralization Rate
Proportion of participants with confirmed primary aldosteronism demonstrating lateralization on adrenal vein sampling.
Time frame: Perioperative/Periprocedural
Phenotypic Differences According to Aldosterone-to-Renin Ratio Range
Comparison of clinical and biochemical characteristics between participants with aldosterone-to-renin ratio values of 20-30 and those with higher aldosterone-to-renin ratio values.
Time frame: Baseline
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