Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism

Sponsor
Bangladesh Medical University
Study ID
NCT07688928
Status
Recruiting
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Conditions

  • Endocrine Hypertension
  • Primary Aldosteronism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily

Study Details

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 Dates

First listed
Jul 7, 2026
Start date
Apr 15, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Tab. Finerenone 10-40mg daily
  • Active Comparator: Spironolactone
    Tab. Spironolactone 25-100mg daily

Primary Outcome Measure

Dose of Finerenone [ Time Frame: 12 month ]

Central Contacts

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