Health Trials

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

ConditionsPrimary AldosteronismEndocrine Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBangladesh Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Finerenone

    Drug

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

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: FinerenoneExperimental treatment 1 intervention
Group B: SpironolactoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 month
2

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

Time frame
12 month

Secondary outcomes

1

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.

Time frame
12 month
2

Change in Blood pressure in ABPM

Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bangladesh Medical University

Lead sponsor

Source ClinicalTrials.gov
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