Primary AldosteronismSCREEN-PANCT07621458
Study on Cutoff Revision Effects and Evaluation of NNT in Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Saline Infusion Test
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with hypertension who have an aldosterone-to-renin ratio (ARR) >20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Jung Hee Kim, +82-02-2072-0694, jhee1@snu.ac.kr
About this study
Official title: Impact of the Revised Aldosterone-Renin Ratio (ARR) Cutoff in the 2025 Primary Aldosteronism Guideline in Real-World Practice: A Prospective Study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Primary Aldosteronism
- Being tested
- Saline Infusion Test
- Keywords
- Primary Aldosteronism, Aldosterone-to-Renin Ratio, Number Needed to Test, Screening
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Infusion TestDiagnostic test
Standardized saline infusion test performed for confirmatory diagnosis of primary aldosteronism.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Saline Infusion Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Complete Biochemical Success After Treatment
Proportion of participants with confirmed primary aldosteronism who achieve complete biochemical success after treatment.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Apr 2026
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gangneung Asan Hospital, Nowon Eulji Medical Center, Inha University Hospital, Asan Medical Center, Samsung Medical Center, Eunpyeong St. Mary's Hospital, Chungnam National University Hospital, Kangbuk Samsung Hospital, Ajou University School of Medicine, Hallym University Dongtan Sacred Heart Hospital, DongGuk University, Korea University Guro Hospital, Chonnam National University Hospital
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621458
- Sponsor's protocol ID
- SCREEN-PA
- Acronym
- SCREEN-PA
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Revised Aldosterone-Renin Ratio (ARR) Cutoff in the 2025 Primary Aldosteronism Guideline in Real-World Practice: A Prospective Study
- ClinicalTrials.gov ID
- NCT07621458
- Acronym / sponsor ID
- SCREEN-PA / SCREEN-PA
- Conditions
- Primary Aldosteronism
- Keywords
- Primary Aldosteronism, Aldosterone-to-Renin Ratio, Number Needed to Test, Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Gangneung Asan Hospital, Nowon Eulji Medical Center, Inha University Hospital, Asan Medical Center, Samsung Medical Center, Eunpyeong St. Mary's Hospital, Chungnam National University Hospital, Kangbuk Samsung Hospital, Ajou University School of Medicine, Hallym University Dongtan Sacred Heart Hospital, DongGuk University, Korea University Guro Hospital, Chonnam National University Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARR >20 Cohort | – | Diagnostic Test: Saline Infusion TestAdults with hypertension who have an aldosterone-to-renin ratio (ARR) >20 and meet criteria for intermediate probability of lateralizing primary aldosteronism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with hypertension who have an aldosterone-to-renin ratio (ARR) >20 and meet criteria for intermediate probability of lateralizing primary aldosteronism.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Infusion TestStandardized saline infusion test performed for confirmatory diagnosis of primary aldosteronism. | Diagnostic test | ARR >20 Cohort |
Primary outcome
Number Needed to Test for Diagnosis of Primary Aldosteronism
Time frame: Through study completion, an average of 6 months
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.
2 secondary outcomes
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
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Related trials for Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Mi Choi (+82-31-8086-3655, ymchoi@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Needed to Test for Diagnosis of Primary Aldosteronism (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.