Early Aldo Blockade in Subclinical PA

ConditionSubclinical Primary Aldosteronism

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age30-55

SponsorXinjiang Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Eplerenone
Drug
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.
Placebo
Drug
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.

Treatment groups

880 Participants

are divided into 2 treatment groups

Group A: Placebo GroupPlacebo comparator 1 intervention

Group B: Eplerenone GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of New-Onset Hypertension

Time frame

Up to 36 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinjiang Medical University

Lead sponsor

Source ClinicalTrials.gov

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