Early Aldo Blockade in Subclinical PA

Korábbi kezelés

• History of diagnosed hypertension, including office BP ≥ 140/90 mmHg, previous use of antihypertensive drugs, or previous ABPM meeting hypertension diagnostic criteria.
• 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.
• Participation in other clinical trials or use of other investigational drugs within 3 months prior to enrollment.

Más betegség

• Other etiologies of secondary hypertension, including renal artery stenosis, pheochromocytoma, Cushing's syndrome, thyroid dysfunction, glucocorticoid-remediable aldosteronism, etc.
• History of allergy to eplerenone or any excipients of the study drug.
• History of adrenal surgery.
• History of drug abuse, alcohol dependence, or psychiatric illness that may affect study completion, as judged by the investigator.
• Any other conditions that, in the opinion of the investigator, may affect subject safety, trial compliance, or outcome assessment.

Laborértékek

• 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).
• 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.

Életkor

• Severe comorbidities with an expected life expectancy of <5 years, including malignant tumors, severe autoimmune diseases, end-stage organ failure, etc.

Egyéb

• Pregnant, lactating women, or subjects planning to become pregnant during the study period.

• 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.