The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Korábbi kezelés

• Use of spironolactone, hydralazine, or minoxidil within 30 days prior to enrollment.
• Concurrent use of potent CYP3A4 inhibitors or inducers for treatment.
• Pregnancy or planning pregnancy within 3 months before or after treatment, and breastfeeding women.

Más betegség

• Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
• Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
• History of adrenal surgery within the past 6 months.
• History of carotid artery surgery within the past 6 months.
• History of arterial vascular reconstruction surgery within the past 6 months.
• Known or suspected tumors; other autoimmune diseases, uncontrolled infectious diseases, severe respiratory, blood, and neurological diseases.
• Mental illness, alcohol or drug abuse, inability to cooperate with treatment.

Laborértékek

• Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels <2.5 or ≥5.0 mmol/L.
• Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN), total bilirubin (TBIL) > 1.5× ULN.

Egyéb

• Orthostatic hypotension.
• Patients with pacemakers.
• Participation in other clinical trials.

• Age:18-75 years old.
• History of hypertension, with a sitting SBP ≥140 and <180 mmHg, and a sitting DBP ≥90 and <120 mmHg during the last two evaluations within the observation period.
• Patients with PA who are eligible for drug treatment.
• Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) >30 (ng/dl)/(ng/ml/h) or ARR >2.4 (ng/dl)/(mU/L), with plasma aldosterone >15 ng/dl and plasma renin activity <1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by <30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
• eGFR ≥60 ml/ (min*1.73m2).
• Signed informed consent form.