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RecruitingNCT07688928Updated Jul 7, 2026

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

An interventional study of Finerenone in Primary Aldosteronism and Endocrine Hypertension, sponsored by Bangladesh Medical University. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Primary Aldosteronism
  • Endocrine Hypertension

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Keywords

  • Primary Aldosteronism
  • Finerenone
  • Spironolactone
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 104 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 () 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: \<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 ≤3 months before the screening visit.
  8. Uncontrolled DM ( >12%)
  9. Hepatic insufficiency ( C)
  10. Addison's disease
  11. Pregnant and lactating women. Women with child bearing potential must agree to use adequate 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 to the study drugs.
  14. Patients unwilling to participate in this study
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Finerenone

    Tab. Finerenone 10-40mg daily

    Drug: Finerenone

  • Active comparator
    Spironolactone

    Tab. Spironolactone 25-100mg daily

    Drug: Finerenone

Interventions

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Endocrine HTN Clinic
    Dhaka, 1000, Bangladesh
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.

Of 35 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2026
First posted
Jul 7, 2026
StartActual
Apr 15, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Sep 2027
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07688928
Lead sponsor
Bangladesh Medical University
Responsible party
Sharmin Jahan (Professor Dr. Sharmin Jahan, Bangladesh Medical University) — Principal investigator
First posted
Jul 7, 2026
Start date
Apr 15, 2026
Primary completion
Mar 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

Sharmin Jahan, PhD
Contact
sharminendo@bsmmu.edu.bd
+8801731061056
Sharmin Jahan, PhD
principal investigator · Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Finerenone

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