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

ConditionsHeart Failure Diabetic Kidney Disease Hyperkalemia

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Finerenone
Drug
Finerenone 10 mg administered orally once daily. Treatment is given in addition to standard of care therapy for heart failure and diabetic kidney disease. Dose interruption or discontinuation may occur according to protocol-defined safety criteria, particularly in the setting of hyperkalemia.
Spironolactone (drug)
Drug
Spironolactone 25 mg administered orally on alternate days. Treatment is given in addition to standard of care therapy for heart failure and diabetic kidney disease. Dose interruption or discontinuation may occur according to protocol-defined safety criteria, particularly in the setting of hyperkalemia.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: FinerenoneExperimental treatment 1 intervention

Group B: Alternate-Day SpironolactoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

Clinically Relevant Hyperkalemia

Clinically relevant hyperkalemia is defined as the occurrence of any of the following: serum potassium ≥ 5.5 mEq/L, temporary or permanent discontinuation or dose adjustment of the study drug due to hyperkalemia, or need for potassium-lowering therapy.

Time frame

Up to 4 weeks after randomization

Secondary outcomes

Change in Serum Potassium

Mean change in serum potassium from baseline to 4 weeks.

Time frame

Baseline to 4 weeks

Time to First Hyperkalemia Event

Time from randomization to first occurrence of serum potassium ≥ 5.5 mEq/L.

Time frame

Up to 4 weeks

Temporary or Permanent Discontinuation of Study Drug

Incidence of temporary or permanent interruption of study drug due to hyperkalemia.

Time frame

Up to 4 weeks

Change in Albuminuria and in Renal Function

Change in urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) from baseline to 4 weeks.

Time frame

Up to 4 weeks.

Other outcomes

Heart Failure Hospitalization

Incidence of hospitalization due to heart failure.

Time frame

Up to 4 weeks

All-Cause Mortality

Incidence of death from any cause.

Time frame

Up to 4 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Lead sponsor

Source ClinicalTrials.gov

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