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NCT Number: NCT07688928

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrine HTN Clinic

Dhaka, 1000, Bangladesh

Location status: Recruiting

Location contact

Sharmin Jahan, PhD

CONTACT

[email protected]

+8801731061056

Sharmin Jahan, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finerenone

Drug

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

Primary outcomes

  1. Dose of Finerenone

    Time frame: 12 month

    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

  2. Time required

    Time frame: 12 month

    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

Secondary outcomes

  1. Change in Systolic and Diastolic Blood Pressure

    Time frame: 12 month

    Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period.

  2. Change in Blood pressure in ABPM

    Time frame: 12 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sharmin Jahan, PhD

CONTACT

[email protected]

+8801731061056

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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