Hyperaldosteronism Clinical Trials

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Impact of the Revised Aldosterone-Renin Ratio (ARR) Cutoff in the 2025 Primary Aldosteronism Guideline in Real-World Practice: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Yun Mi Choi
ymchoi@hallym.or.kr
+82-31-8086-3655
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
ARR >20 Cohort
Adults with hypertension who have an aldosterone-to-renin ratio (ARR) \>20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Related Therapeutic Areas
Sponsors
Collaborators: Asan Medical Center, Chonnam National University Hospital, Kangbuk Samsung Hospital, Nowon Eulji Medical Center, Korea University Guro Hospital, Ajou University School of Medicine, Chungnam National University Hospital, DongGuk University, Hallym University Dongtan Sacred Heart Hospital, Eunpyeong St. Mary's Hospital, Samsung Medical Center, Gangneung Asan Hospital, Inha University Hospital
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov