NCT07523867Not yet recruitingPhase 4
Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study
Safety of Finerenone Versus Alternate-Day Spironolactone in Patients With Heart Failure and Diabetic Kidney Disease at High Risk for Hyperkalemia: The SAFE-K Randomized Trial
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Apr 2026
- Start date
- Apr 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Hospital de Messejana Dr. Carlos Alberto Studart Gomes
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT07523867
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From Apr 2026 to the primary completion date, Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically significant arrhythmias requiring immediate intervention
- Known hypersensitivity or contraindication to finerenone or spironolactone
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures
Lab values
- Serum potassium \> 5.5 mEq/L at screening
- Use of potassium-sparing diuretics other than the study drugs
Other
- Acute kidney injury at the time of enrollment
- Symptomatic hypotension or systolic blood pressure \< 90 mmHg
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
Who the study is looking for
- 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)
- Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m²
- Serum potassium between 5.0 and 5.5 mEq/L at screening
- Receiving or eligible to receive standard of care therapy for heart failure
- Ability to provide written informed consent
- Ability to comply with study procedures and follow-up visits
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.