Not Yet RecruitingPhase 4

Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study

60 participantsStarted 2026-04

Plain-language summary

This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia. Patients with chronic kidney disease and heart failure often benefit from mineralocorticoid receptor antagonists, but their use is frequently limited by elevated potassium levels. Finerenone has been associated with a lower risk of hyperkalemia in clinical trials, but direct comparisons with spironolactone in high-risk patients are limited. In this randomized study, eligible participants will be assigned to receive either finerenone once daily or spironolactone on alternate days, in addition to standard therapy. Patients will be closely monitored during hospitalization and followed for 4 weeks. The primary outcome is clinically relevant hyperkalemia, defined by elevated potassium levels or the need to adjust or discontinue treatment due to hyperkalemia. Secondary outcomes include changes in potassium levels, kidney function, and clinical events. This study aims to provide practical evidence to guide the safe use of mineralocorticoid receptor antagonists in patients at high risk for hyperkalemia.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

What they're measuring

Clinically Relevant Hyperkalemia

Timeframe: Up to 4 weeks after randomization

Trial details

NCT IDNCT07523867

SponsorHospital de Messejana Dr. Carlos Alberto Studart Gomes

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Jefferson L Vieira, MD, PHD

+5585981236289 unidadepesquisaclinica@gmail.com