Study on Cutoff Revision Effects and Evaluation of NNT in Primary Aldosteronism

NCT07621458 | Recruiting DMC

• 1 other identifier: SCREEN-PA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Aldosteronism; Aldosterone-to-Renin Ratio; Number Needed to Test; Screening

Outcome Measures

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.

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Complete Biochemical Success After Treatment

  Through study completion, an average of 6 months

• Optimal Aldosterone-to-Renin Ratio Cutoff for Diagnosis of Primary Aldosteronism

  Through study completion, an average of 6 months

Other Outcomes (2)

• Adrenal Vein Sampling Lateralization Rate

  Perioperative/Periprocedural

• Phenotypic Differences According to Aldosterone-to-Renin Ratio Range

  Baseline

Study Arms (1)

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.

Diagnostic Test: Saline Infusion Test

Interventions

Saline Infusion Test DIAGNOSTIC_TEST

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

ARR >20 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with hypertension who have an aldosterone-to-renin ratio (ARR) \>20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Nowon Eulji Medical Center: collaborator
• Inha University Hospital: collaborator
• Eunpyeong St. Mary's Hospital: collaborator
• DongGuk University: collaborator
• Korea University Guro Hospital: collaborator
• Samsung Medical Center: collaborator
• Hallym University Dongtan Sacred Heart Hospital: collaborator
• Gangneung Asan Hospital: collaborator
• Asan Medical Center: collaborator
• Chungnam National University Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• Ajou University School of Medicine: collaborator
• Chonnam National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Korea, Republic of, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Yun Mi Choi

CONTACT

+82-31-8086-3655; ymchoi@hallym.or.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

KR (1)