Subclinical Primary AldosteronismPhase 2/3EARLY-PANCT07727252
Early Aldo Blockade in Subclinical PA
A Phase 2/3 study testing Eplerenone in people with Subclinical Primary Aldosteronism, run by Xinjiang Medical University.
Trial summary
This trial aims to evaluate the preventive effect of early intervention with eplerenone, a highly selective nonsteroidal mineralocorticoid receptor antagonist, against new-onset hypertension in normotensive patients with subclinical primary aldosteronism (PA), as well as its cardiorenal target organ protective effects… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Subclinical Primary Aldosteronism
- What is being tested?
- Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2029
- Phase
- Phase 2/3
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30 to 55 years old (inclusive), both genders.
- Body Mass Index (BMI) 18.5 to 35.0 kg/m² (inclusive).
- Office blood pressure < 140/90 mmHg, and no use of any antihypertensive drugs. Office blood pressure is measured at 3 visits with 1-week intervals. Patients rest in a seated position for 5 minutes before measurement, measured -times per visit, and the average of the 3 visits must meet the criteria.
- Serum potassium in the low-normal or normal range.
- Meeting diagnostic criteria: (A) ARR ≥ 2.52 ng/dL per pg/mL (chemiluminescence immunoassay), and PAC ≥ 6 ng/dL (blood sample required in the morning, fasting, after resting in a seated position for 30 minutes); OR (B) Renin ≤ 4.0 pg/mL; OR (C) Positive confirmatory test: Saline infusion test (SIT): PAC > 6 ng/dL after 4 hours of isotonic saline infusion; OR Captopril challenge test (CCT): PAC suppression rate < 30% at 2 hours after oral administration of 50mg captopril.
- Adrenal thin-slice CT showing unilateral adrenal nodule (<15 mm in diameter), bilateral adrenal micronodules (<10 mm in diameter), or negative findings.
Who cannot join
- History of diagnosed hypertension, including office BP ≥ 140/90 mmHg, previous use of antihypertensive drugs, or previous ABPM meeting hypertension diagnostic criteria.
- Other etiologies of secondary hypertension, including renal artery stenosis, pheochromocytoma, Cushing's syndrome, thyroid dysfunction, glucocorticoid-remediable aldosteronism, etc.
- Severe renal insufficiency: eGFR < 45 mL/min/1.73m² (CKD-EPI formula), or UACR > 300 mg/g.
- Abnormal baseline serum potassium: serum potassium > 5.0 mmol/L, or serum potassium < 3.0 mmol/L.
- Severe hepatic insufficiency: Child-Pugh Class C, or ALT/AST > 3 times the upper limit of normal (ULN).
- History of allergy to eplerenone or any excipients of the study drug.
Show all 14Show fewer
- Pregnant, lactating women, or subjects planning to become pregnant during the study period.
- History of adrenal surgery.
- Severe cardiovascular diseases, including New York Heart Association (NYHA) Class IV heart failure, previous myocardial infarction, cerebral infarction, transient ischemic attack (TIA), severe arrhythmia, etc.
- Severe comorbidities with an expected life expectancy of <5 years, including malignant tumors, severe autoimmune diseases, end-stage organ failure, etc.
- Use of drugs that cannot be discontinued prior to enrollment: strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, nefazodone, etc.); strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's wort, etc.); other MRAs, potassium-sparing diuretics (amiloride, triamterene), potassium supplements; systemic glucocorticoids (except physiological replacement), licorice preparations; long-term high-dose NSAIDs.
- History of drug abuse, alcohol dependence, or psychiatric illness that may affect study completion, as judged by the investigator.
- Participation in other clinical trials or use of other investigational drugs within 3 months prior to enrollment.
- Any other conditions that, in the opinion of the investigator, may affect subject safety, trial compliance, or outcome assessment.
About this study
Official title: Early Aldosterone Blockade to Prevent Hypertension and Cardiorenal Damage in Subclinical Primary Aldosteronism
This trial aims to evaluate the preventive effect of early intervention with eplerenone, a highly selective nonsteroidal mineralocorticoid receptor antagonist, against new-onset hypertension in normotensive patients with subclinical primary aldosteronism (PA), as well as its cardiorenal target organ protective effects and long-term safety profile.
The trial will be conducted across 15 to 20 tertiary hospitals nationwide with established expertise in PA diagnosis and management. A total of 880 eligible patients aged 30 to 55 years with normal blood pressure and biochemically/functionally confirmed subclinical PA will be enrolled and randomly assigned to the eplerenone group or the placebo group at a 1:1 ratio. The eplerenone group will receive a dose titration regimen with a target maintenance dose of 50 mg once daily orally, while the placebo group will follow a matched sham titration protocol. The double-blind treatment period will last 3 years, with an extension to 5 years permitted based on interim analysis findings.
Read more
The primary endpoint is the incidence of new-onset hypertension within 3 years, adjudicated blindly by an independent Clinical Endpoint Committee (CEC). Secondary endpoints include alterations in biomarkers of cardiorenal target organ damage, improvements in endocrine parameters, changes in adrenal nodule volume, and patient-reported outcomes. Safety endpoints cover the incidence of adverse events such as hyperkalemia, acute kidney injury, and hypotension.
This trial will fill a critical gap in evidence-based medicine regarding early intervention for subclinical PA for the first time. Its findings are expected to revise international clinical practice guidelines for PA and deliver a novel precision intervention strategy for the primary prevention of hypertension.
- Conditions
- Subclinical Primary Aldosteronism
- Being tested
- Eplerenone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Eplerenone tablets, starting dose 25mg once daily orally. At Week 4 visit, titrate to 50mg once daily if serum potassium <=4.5 mmol/L and eGFR decrease from baseline <30%; maintain 25mg once daily if serum potassium 4.6-5.0 mmol/L; hold drug if potassium >5.0 mmol/L or eGFR decrease >=30%. At Week 8 visit, maintain the stable titrated dose for continuation until the end of the study. Long-term dose adjustment during follow-up will be performed according to the specific protocol Table 1 if potassium/eGFR abnormalities occur.
PlaceboDrug
Placebo tablets completely matching the appearance, specifications, smell, and packaging of Eplerenone tablets, with no pharmacological activity. A sham titration scheme is adopted that is completely consistent with the Eplerenone group (including dose adjustment processes and follow-up monitoring) to strictly maintain the double-blind design.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
| Eplerenone Group | Experimental | Not described Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New-Onset Hypertension
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical Primary AldosteronismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727252
- Sponsor's protocol ID
- 260610-06
- Acronym
- EARLY-PA
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Aldosterone Blockade to Prevent Hypertension and Cardiorenal Damage in Subclinical Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07727252
- Acronym / sponsor ID
- EARLY-PA / 260610-06
- Conditions
- Subclinical Primary Aldosteronism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 27 Jul 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.
This trial aims to evaluate the preventive effect of early intervention with eplerenone, a highly selective nonsteroidal mineralocorticoid receptor antagonist, against new-onset hypertension in normotensive patients with subclinical primary aldosteronism (PA), as well as its cardiorenal target organ protective effects and long-term safety profile.
The trial will be conducted across 15 to 20 tertiary hospitals nationwide with established expertise in PA diagnosis and management. A total of 880 eligible patients aged 30 to 55 years with normal blood pressure and biochemically/functionally confirmed subclinical PA will be enrolled and randomly assigned to the eplerenone group or the placebo group at a 1:1 ratio. The eplerenone group will receive a dose titration regimen with a target maintenance dose of 50 mg once daily orally, while the placebo group will follow a matched sham titration protocol. The double-blind treatment period will last 3 years, with an extension to 5 years permitted based on interim analysis findings.
The primary endpoint is the incidence of new-onset hypertension within 3 years, adjudicated blindly by an independent Clinical Endpoint Committee (CEC). Secondary endpoints include alterations in biomarkers of cardiorenal target organ damage, improvements in endocrine parameters, changes in adrenal nodule volume, and patient-reported outcomes. Safety endpoints cover the incidence of adverse events such as hyperkalemia, acute kidney injury, and hypotension.
This trial will fill a critical gap in evidence-based medicine regarding early intervention for subclinical PA for the first time. Its findings are expected to revise international clinical practice guidelines for PA and deliver a novel precision intervention strategy for the primary prevention of hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo |
| Eplerenone Group | Experimental | Drug: Eplerenone |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 30 to 55 years old (inclusive), both genders.
- Body Mass Index (BMI) 18.5 to 35.0 kg/m² (inclusive).
- Office blood pressure < 140/90 mmHg, and no use of any antihypertensive drugs. Office blood pressure is measured at 3 visits with 1-week intervals. Patients rest in a seated position for 5 minutes before measurement, measured -times per visit, and the average of the 3 visits must meet the criteria.
- Serum potassium in the low-normal or normal range.
- Meeting diagnostic criteria: (A) ARR ≥ 2.52 ng/dL per pg/mL (chemiluminescence immunoassay), and PAC ≥ 6 ng/dL (blood sample required in the morning, fasting, after resting in a seated position for 30 minutes); OR (B) Renin ≤ 4.0 pg/mL; OR (C) Positive confirmatory test: Saline infusion test (SIT): PAC > 6 ng/dL after 4 hours of isotonic saline infusion; OR Captopril challenge test (CCT): PAC suppression rate < 30% at 2 hours after oral administration of 50mg captopril.
Key exclusion criteria (14 listed)
- History of diagnosed hypertension, including office BP ≥ 140/90 mmHg, previous use of antihypertensive drugs, or previous ABPM meeting hypertension diagnostic criteria.
- Other etiologies of secondary hypertension, including renal artery stenosis, pheochromocytoma, Cushing's syndrome, thyroid dysfunction, glucocorticoid-remediable aldosteronism, etc.
- Severe renal insufficiency: eGFR < 45 mL/min/1.73m² (CKD-EPI formula), or UACR > 300 mg/g.
- Abnormal baseline serum potassium: serum potassium > 5.0 mmol/L, or serum potassium < 3.0 mmol/L.
- Severe hepatic insufficiency: Child-Pugh Class C, or ALT/AST > 3 times the upper limit of normal (ULN).
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 |
|---|---|---|
| EplerenoneEplerenone tablets, starting dose 25mg once daily orally. At Week 4 visit, titrate to 50mg once daily if serum potassium <=4.5 mmol/L and eGFR decrease from baseline <30%; maintain 25mg once daily if serum potassium 4.6-5.0 mmol/L; hold drug if potassium >5.0 mmol/L or eGFR decrease >=30%. At Week 8 visit, maintain the stable titrated dose for continuation until the end of the study. Long-term dose adjustment during follow-up will be performed according to the specific protocol Table 1 if potassium/eGFR abnormalities occur. | Drug | Eplerenone Group |
| PlaceboPlacebo tablets completely matching the appearance, specifications, smell, and packaging of Eplerenone tablets, with no pharmacological activity. A sham titration scheme is adopted that is completely consistent with the Eplerenone group (including dose adjustment processes and follow-up monitoring) to strictly maintain the double-blind design. | Drug | Placebo Group |
Primary outcome
Incidence of New-Onset Hypertension
Time frame: Up to 36 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 27 Jul 2026.
Related trials for Subclinical Primary Aldosteronism
Active, not recruitingEarly Phase 1
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
Type 2 Diabetes, Chronic Kidney Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eplerenone in people with Subclinical Primary Aldosteronism, run by Xinjiang Medical University.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Hypertension (time frame: Up to 36 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 27 Jul 2026.