Study on Cutoff Revision Effects and Evaluation of NNT in 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.

Conditions

• Primary Aldosteronism

Interventions

DIAGNOSTIC_TEST

Saline Infusion Test

Standardized saline infusion test performed for confirmatory diagnosis of primary aldosteronism.

Sponsors & Collaborators

• Gangneung Asan Hospital

  collaborator OTHER

• Nowon Eulji Medical Center

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Eunpyeong St. Mary's Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• Hallym University Dongtan Sacred Heart Hospital

  collaborator OTHER

• DongGuk University

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2027-05-01

Completion

2027-12-31

Countries

• South Korea

Study Locations