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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Messejana Dr. Carlos Alberto Studart Gomes

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Finerenone
  • Spironolactone (drug)

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations