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Early Aldo Blockade in Subclinical PA

NCT07727252 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2026-07-27

No results posted yet for this study

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 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.

Conditions

  • Subclinical Primary Aldosteronism

Interventions

DRUG

Eplerenone

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Xinjiang Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-08-01
Completion
2029-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727252 on ClinicalTrials.gov