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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism; Endocrine Hypertension
• Intervention / Treatment: Drug: Finerenone

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharmin Jahan, PhD; Phone Number: +8801731061056; Email: sharminendo@bsmmu.edu.bd

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Recruiting
    • Endocrine HTN Clinic
    • Contact: Sharmin Jahan, PhD; Phone Number: +8801731061056; Email: sharminendo@bsmmmu.edu.bd
    • Principal Investigator: Sharmin Jahan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age >18 years.
2. History of hypertension (blood pressure >140/90 mm Hg), both newly detected and already established patients.
3. Diagnosed case of primary aldosteronism (PA) based on a screening test (increased aldosterone renin ration (ARR) >70pmol/L) and confirmed by saline suppression test (post-saline PAC >170pmol/L, where PAC measured by immunoassay).
4. Serum potassium ≥2.5 mmol/L.

Exclusion Criteria:

1. Uncontrolled hypertension (>180/120 mm Hg).
2. Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
3. Participants already with mineralocorticoid receptor antagonist treatment.
4. Patients receiving medications confounding PAC or PRC (glucocorticoids, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, clarithromycin, rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz) that cannot be discontinued 14 days prior to randomization or for the duration of treatment period.
5. Abnormal renal function test: eGFR <60 ml/min-1.73m2.
6. Serum potassium level >5 mmol/L.
7. Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
8. Uncontrolled DM (HbA1C >12%)
9. Hepatic insufficiency (Child-Pugh C)
10. Addison's disease
11. Pregnant and lactating women. Women with child bearing potential must agree to use adequate contraception during and until 2 month of the end of study period.
12. Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
13. Known hypersensitivity to the study drugs.
14. Patients unwilling to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone; Tab. Finerenone 10-40mg daily	Drug: Finerenone; All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily
Active Comparator: Spironolactone; Tab. Spironolactone 25-100mg daily	Drug: Finerenone; All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of Finerenone	daily dose of finerenone required for attainment of composite endpoints of target blood pressure (<140/90 mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA	12 month
Time required	Time required for attainment of composite endpoints of target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic and Diastolic Blood Pressure	Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period.	12 month
Change in Blood pressure in ABPM	Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).	12 month

Collaborators and Investigators

• Sponsor: Bangladesh Medical University
• Investigators: Principal Investigator: Sharmin Jahan, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Spironolactone; Primary Aldosteronism; Finerenone
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; finerenone
• Other Study ID Numbers: PR-1418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No