NCT07688928Recruiting
Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Apr 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Bangladesh Medical University
- Diseases
- High blood pressure
- NCT number
- NCT07688928
What you commit to
- Study type: Interventional
- Planned participants: 104
- From Apr 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
Other illness
- Uncontrolled hypertension (\>180/120 mm Hg).
- Hepatic insufficiency (Child-Pugh C)
- Addison's disease
- Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
- Known hypersensitivity to the study drugs.
Lab values
- 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.
- Uncontrolled DM (HbA1C \>12%)
Other
- 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.
- 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.
- Patients unwilling to participate in this study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Endocrine HTN Clinic Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.