Swedish Cardiac And Renal Failure Study-1

Launched by KAROLINSKA INSTITUTET · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Swedish Cardiac And Renal Failure Study-1, is looking at whether a medication named eplerenone is safe and helpful for people who have both heart failure with reduced pumping ability and kidney problems. While eplerenone has been shown to help heart failure patients with healthy kidneys, those with poorer kidney function have usually been left out of previous studies because of concerns about side effects like changes in potassium levels or worsening kidney function. This study aims to see if eplerenone can be safely used in this high-risk group and whether it might improve their condition.

People who might be eligible to join are adults aged 65 to 74 who have had heart failure with reduced heart function for at least three months, confirmed by recent heart tests, and who have stable treatment for their heart condition. They must also have moderately reduced kidney function, but not so severe that dialysis is needed. Participants will be carefully monitored to check for any side effects and to see how well the medication works. This is an early, smaller study designed to test safety and feasibility before larger trials are done. If you or a loved one fits these criteria and are interested, it’s important to talk with your doctor to understand if this trial could be a good option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The participant has given their written consent to participate
• • A diagnosis of HFrEF according to current criteria, for at least three months before the screening visit
• • Echocardiography within 24 months of the screening visit with ejection fraction ≤ 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 beta-blockers, sodium/glucose co-transporter 2 inhibitors, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers if eGFR ≥ 20 ml/min/1.73m2 according to the revised Lund-Malmö method. 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 before the screening visit, and eGFR \< 45 ml/min/1.73m2 at the time of inclusion
• Exclusion Criteria:
• • P-K ≥ 5.6
• • 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 methods, or ongoing/planned pregnancy, or breastfeeding
• • Previous allergic reaction to an MRA or a potassium binder
• • 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 Wort)
• • QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome
• • Uncontrolled arrhythmia as judged by the investigator
• • 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