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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.
EU CTIS ID: 2025-520550-11-00
What this study is testing
To conduct a pilot trial to evaluate the feasibility and safety of eplerenone in patients with HFrEF and severe CKD. An exploratory analysis of efficacy will also be performed.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written consent to participate
- Age ≥ 18
- A diagnosis of HFrEF according to current criteria since at least three months prior to the screening visit
- Echocardiography within 24 months of the screening visit with EF ≤ 40%
- New York Heart Association class II-III
- Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include BBs, SGLT2Is, ACEIs, or ARBs if eGFR ≥ 20 ml/min/1.73m2 according to the revised Lund-Malmö method. 20 Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines
You likely can't join if
- P-K ≥ 5.5
- Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s worth)
- QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome
- Uncontrolled arrythmia as judged by the investigator
- Acute cardiac hospitalization or procedure within four weeks
- Acute cardiac hospitalization or procedure within four weeks before inclusion
See the full eligibility criteria
- The subject has given their written consent to participate
- Age ≥ 18
- A diagnosis of HFrEF according to current criteria since at least three months prior to the screening visit
- Echocardiography within 24 months of the screening visit with EF ≤ 40%
- New York Heart Association class II-III
- Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include BBs, SGLT2Is, ACEIs, or ARBs if eGFR ≥ 20 ml/min/1.73m2 according to the revised Lund-Malmö method. 20 Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines
- eGFR < 30 ml/min/1.73m2 according to the revised Lund-Malmö method at least once during the 12 months prior to the screening visit and eGFR < 45 ml/min/1.73m2 at the time of inclusion
- P-K ≥ 5.5
- Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s worth)
- QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome
- Uncontrolled arrythmia as judged by the investigator
- Acute cardiac hospitalization or procedure within four weeks
- Acute cardiac hospitalization or procedure within four weeks before inclusion
- Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity and expected survival < 12 months)
- Previously enrolled in this trial or participation in another trial not approved for co-enrollment
- eGFR < 10 ml/min/1.73m2 according to the revised Lund-Malmö method.
- Ongoing/planned dialysis
- Systolic blood pressure < 90 mmHg
- Uncontrolled hypertension as judged by the investigator
- Severe hepatic impairment (Child-Pugh C)
- History of, or planned, heart transplantation or left ventricular assist device
- Unwillingness to comply with highly effective contraceptive methos, or ongoing/planned pregnancy or breastfeeding
- Previous allergic reaction to a MRA or a potassium binder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.