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New study aims to find safer heart failure treatment for kidney patients

NCT ID NCT07523867

Disease control Sponsor: Hospital de Messejana Dr. Carlos Alberto Studart Gomes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two drugs, finerenone and spironolactone, in 60 adults with heart failure and diabetic kidney disease who are at high risk for high potassium levels (hyperkalemia). Participants will receive either finerenone daily or spironolactone every other day, plus standard care, and be monitored for 4 weeks. The goal is to see which drug is safer by tracking potassium levels and any need to stop or adjust treatment.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Age ≥ 18 years * Diagnosis of heart failure, regardless of left ventricular ejection fraction * Diagnosis of type 2 diabetes mellitus * Diabetic kidney disease, defined by the presence of albuminuria (urinary albumin-to-creatinine ratio ≥ 30 mg/g) * Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m² * Serum potassium between 5.0 and 5.5 mEq/L at screening * Receiving or eligible to receive standard of care therapy for heart failure * Ability to provide written informed consent * Ability to comply with study procedures and follow-up visits Exclusion Criteria: * Serum potassium \> 5.5 mEq/L at screening * Acute kidney injury at the time of enrollment * Symptomatic hypotension or systolic blood pressure \< 90 mmHg * Clinically significant arrhythmias requiring immediate intervention * Known hypersensitivity or contraindication to finerenone or spironolactone * Use of potassium-sparing diuretics other than the study drugs * Pregnancy or breastfeeding * Participation in another interventional clinical trial * Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures

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Conditions

The condition(s) this trial relates to.

cardio-renal syndrome chronic renal failure syndrome diabetic kidney disease heart failure Hyperkalemia

As listed by the trial registrant

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

Diabetic kidney disease Heart failure Hyperkalemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.