Finerenone vs. Spironolactone for Primary Aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, active-controlled study enrolling 104 adults with confirmed primary aldosteronism at the Endocrine Hypertension Clinic in Dhaka. Participants will be assigned to finerenone (10-40 mg/day) or spironolactone (25-100 mg/day) for 48 weeks, with dosing adjusted to reach a target blood pressure under 140/90 mmHg and a specific renin level. The primary outcome is the time and daily dose needed to achieve the composite endpoint of blood pressure control and unsuppressed plasma renin concentration. Secondary outcomes include changes in clinic and ambulatory blood pressure, aldosterone and renin levels, kidney function, urinary albumin, left ventricular mass index, and quality of life. Safety will be monitored throughout.

Why it matters

Who can join: the full rules

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

Where it's running

• Endocrine HTN Clinic
  Dhaka, Bangladesh Recruiting

Study contacts

• Principal investigator: Sharmin Jahan, PhD — Professor
• Study coordinator: Sharmin Jahan, PhD
• Email: sharminendo@bsmmu.edu.bd
• Phone: +8801731061056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.