Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Nanjing University

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypertension; Primary Aldosteronism

Treatments: Drug: Finerenone; Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT05814770

PA2023

Details and patient eligibility

About

Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Age: 18-75 years old.
• 2.History of hypertension, DBP <120 mmHg, SBP <180 mmHg.
• 3.Serum potassium level ≥ 2.5 mmol/L.
• 4.Primary Aldosteronis diagnosed by increased aldosterone renin ratio (ARR) > 30 ng/dl: ng/ml/h, and serum aldosterone levels ≥15 ng / dl, and confirmed by captopril inhibition test.

Exclusion criteria

• 1. Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR ≤ 60 ml/(min * 1.73m2);
• 2. Abnormal liver function: ALT and AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN；
• 3. Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
• 4. Take spironolactone, guanethidine or reserpine 30 days before enrollment;
• 5. Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
• 6. There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
• 7. Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Finerenone

Experimental group

Treatment:

Drug: Finerenone

Spironolactone

Active Comparator group

Treatment:

Drug: Spironolactone