RecruitingPhase 2NCT07029503

Swedish Cardiac And Renal Failure Study-1

Swedish Cardiac And Renal Failure Study-1 (SCARF-1): An Open-Label Pilot Trial to Evaluate the Feasibility, Safety and Efficacy of Eplerenone in Patients With Heart Failure With Reduced Ejection Fraction and Severe Chronic Kidney Disease

Sponsor

Karolinska Institutet

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease HFrEF - Heart Failure With Reduced Ejection Fraction

Summary

Previous studies have shown that patients with heart failure with reduced pumping function and preserved kidney function experience improved symptoms, longer survival, and fewer hospitalizations when treated with medications such as eplerenone. However, individuals with impaired kidney function have been excluded from these trials due to concerns about potential adverse effects on potassium levels, kidney function, and possibly also blood pressure. As a result, clear treatment recommendations for this high-risk group are lacking. In recent years, however, background therapies have been modernized and are now associated with a lower risk of potassium disturbances. Preliminary data also suggest that patients with impaired kidney function may benefit from eplerenone treatment. However, confirmation through dedicated studies is needed. The primary objective of this pilot trial is to assess the feasibility and safety of eplerenone in patients with heart failure with reduced pumping function and impaired kidney function. Treatment effectiveness will also be explored.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SCARF-1) is looking at how heart failure with reduced pump function affects the kidneys over time, and whether current heart failure medications adequately protect kidney function in Swedish patients. **You may be eligible if:** - You have given written consent to participate - You have been diagnosed with heart failure with reduced ejection fraction (your heart pumps less than 40% of blood out per beat) for at least 3 months - You have had a heart ultrasound (echocardiogram) within the past 2 years confirming reduced heart function - You are being managed at a participating Swedish hospital **You may NOT be eligible if:** - Your heart function has recovered (ejection fraction above 40%) on a recent echocardiogram - You have a condition that would make participation unsafe or unreliable - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEplerenone

Participants will receive eplerenone 25 mg once daily or every other day, based on baseline potassium levels, eGFR, systolic blood pressure, and concomitant use of weak or moderate CYP3A4 inhibitors. The study will implement a safety protocol with predefined procedures for managing significant hyperkalemia, worsening renal function, and hypotension. These will include temporary or permanent dose reduction or discontinuation of eplerenone, and, if necessary, administration of the potassium binder sodium zirconium cyclosilicate (SZC, Lokelma®).