New drug may offer safer option for Hormone-Driven high blood pressure

NCT ID NCT07688928

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a newer drug, finerenone, works better and is safer than the standard drug spironolactone for people with high blood pressure due to primary aldosteronism—a condition where the adrenal glands make too much of the hormone aldosterone. About 104 adults with this condition will receive either finerenone or spironolactone for 48 weeks, with doses adjusted to reach target blood pressure and hormone levels. The trial measures how quickly and at what dose each drug achieves control, along with effects on kidney function, heart structure, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Finerenone
What this could lead to
If finerenone works better or has fewer side effects than spironolactone, it could become a new standard treatment for primary aldosteronism.
What could go wrong
This is a single-center trial with 104 participants, so results may not apply broadly. Both drugs can cause high potassium levels or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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 (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. 5. Abnormal renal function test: eGFR \<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 transient ischemic attack ≤3 months before the screening visit. 8. Uncontrolled DM (HbA1C \>12%) 9. Hepatic insufficiency (Child-Pugh C) 10. Addison's disease 11. 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. 12. Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.) 13. Known hypersensitivity to the study drugs. 14. Patients unwilling to participate in this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Endocrine HTN Clinic

    RECRUITING

    Dhaka, 1000, Bangladesh

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