Study on Cutoff Revision Effects and Evaluation of NNT in Primary Aldosteronism
ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeoul National University Hospital
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
This trial does not accept healthy volunteersQualifiers
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 population
Adults with hypertension who have an aldosterone-to-renin ratio (ARR) \>20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Saline Infusion Test
Diagnostic testStandardized saline infusion test performed for confirmatory diagnosis of primary aldosteronism.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: ARR >20 Cohort1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 monthsOther outcomes
1
Adrenal Vein Sampling Lateralization Rate
Proportion of participants with confirmed primary aldosteronism demonstrating lateralization on adrenal vein sampling.
Time frame
Perioperative/Periprocedural2
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
BaselineSponsors and contacts
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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
Source ClinicalTrials.gov