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

NCT07688928 | Recruiting DMC

• 1 other identifier: PR-1418
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Endocrine Hypertension; Primary Aldosteronism

Keywords

Primary Aldosteronism; Finerenone; Spironolactone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Systolic and Diastolic Blood Pressure

  12 month

• Change in Blood pressure in ABPM

  12 month

Study Arms (2)

Finerenone

EXPERIMENTAL

Tab. Finerenone 10-40mg daily

Drug: Finerenone

Spironolactone

ACTIVE COMPARATOR

Tab. Spironolactone 25-100mg daily

Drug: Finerenone

Interventions

Finerenone DRUG

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

Finerenone; Spironolactone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• History of hypertension (blood pressure \>140/90 mm Hg), both newly detected and already established patients.
• 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).
• Serum potassium ≥2.5 mmol/L.

You may not qualify if:

• Uncontrolled hypertension (\>180/120 mm Hg).
• Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
• Participants already with mineralocorticoid receptor antagonist treatment.
• 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.
• Abnormal renal function test: eGFR \<60 ml/min-1.73m2.
• Serum potassium level \>5 mmol/L.
• Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
• Uncontrolled DM (HbA1C \>12%)
• Hepatic insufficiency (Child-Pugh C)
• Addison's disease
• 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.
• Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
• Known hypersensitivity to the study drugs.
• Patients unwilling to participate in this study

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Endocrine HTN Clinic

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

finerenone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Sharmin Jahan, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmin Jahan, PhD

CONTACT

+8801731061056; sharminendo@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Sharmin Jahan

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)