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

Overview

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.

Interventions

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

Primary outcome measures

• Dose of Finerenone [Time frame: 12 month]
• Time required [Time frame: 12 month]

Secondary outcome measures (2)

• Change in Systolic and Diastolic Blood Pressure [Time frame: 12 month]
• Change in Blood pressure in ABPM [Time frame: 12 month]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Bangladesh · 1 center

• Endocrine HTN Clinic — Dhaka

Identifiers

NCT: NCT07688928 · PR-1418

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗