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

NCT07688928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Primary Aldosteronism
  • Endocrine Hypertension

Interventions

DRUG

Finerenone

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

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Principal Investigators

  • Sharmin Jahan, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688928 on ClinicalTrials.gov