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Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
Sponsor: Bangladesh Medical University
Summary
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism. It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (\<140/90mmHg) and unsuppressed plasma renin concentration (\>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2026-04-15
Completion Date
2027-09
Last Updated
2026-07-07
Healthy Volunteers
No
Interventions
Finerenone
All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily
Locations (1)
Endocrine HTN Clinic
Dhaka, Bangladesh