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

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.

NCT Number	NCT07523867
Lead Sponsor	Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Conditions	Heart Failure, Diabetic Kidney Disease, Hyperkalemia
Enrollment	60 participants
Start Date	2026-04
Primary Completion	2026-10 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-05-13