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

This is a prospective, randomized, open-label, blinded endpoint (PROBE), single-center study designed to compare the safety of finerenone versus alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia. Mineralocorticoid receptor antagonists (MRAs) are a cornerstone therapy in patients with heart failure and have demonstrated benefits in patients with diabetic kidney disease. However, their use is often limited by hyperkalemia, particularly in patients with impaired renal function and elevated baseline potassium levels. Finerenone, a non-steroidal MRA, has shown a more favorable safety profile compared to steroidal MRAs in previous trials, but direct head-to-head comparisons in high-risk populations are lacking. Eligible participants will be adults with heart failure and diabetic kidney disease with elevated baseline potassium levels. After providing informed consent, participants will be randomized in a 1:1 ratio to receive either finerenone once daily or spironolactone administered on alternate days, in addition to standard of care therapy. Participants will undergo intensive monitoring during hospitalization, including daily assessment of serum potassium and renal function for up to 7 days or until discharge. After hospital discharge, participants will be followed in the outpatient setting for a total of 4 weeks, with scheduled visits and laboratory monitoring. The primary endpoint is the incidence of clinically relevant hyperkalemia within 4 weeks, defined as serum potassium ≥ 5.5 mEq/L, treatment interruption or dose adjustment due to hyperkalemia, or the need for potassium-lowering therapy. Secondary endpoints include change in serum potassium levels, time to first hyperkalemia event, incidence of severe hyperkalemia (≥ 6.0 mEq/L), treatment discontinuation, changes in renal function, and exploratory clinical outcomes such as heart failure hospitalization, arrhythmias, and all-cause mortality. This study aims to provide pragmatic, clinically applicable evidence to inform the use of MRAs in a high-risk cardiorenal population.