Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study (NCT07523867) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study
60 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Known hypersensitivity or contraindication to finerenone or spironolactone
* Use of potassium-sparing diuretics other than the study drugs
* Pregnancy or breastfeeding
* Participation in another interventional clinical trial
* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically Relevant Hyperkalemia
Timeframe: Up to 4 weeks after randomization
Trial details
NCT IDNCT07523867
SponsorHospital de Messejana Dr. Carlos Alberto Studart Gomes