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

NCT07523867 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Finerenone

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.

DRUG

Spironolactone (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.

Sponsors & Collaborators

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523867 on ClinicalTrials.gov