Actively Recruiting
Swedish Cardiac And Renal Failure Study-1
Led by Karolinska Institutet · Updated on 2026-02-24
40
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Swedish Cardiac And Renal Failure Study-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant has given their written consent to participate
- Diagnosis of heart failure with reduced ejection fraction (HFrEF) for at least three months before screening
- Echocardiography within 24 months showing ejection fraction 40% or less; new echocardiography allowed if clinically indicated
- New York Heart Association class II or III
- Stable and optimally treated HFrEF for at least four weeks before screening, including beta-blockers, sodium/glucose co-transporter 2 inhibitors, and ACE inhibitors or ARBs if eGFR 20 ml/min/1.73m2
- Cardiac resynchronization therapy or implantable cardioverter-defibrillator if indicated
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2 at least once in the past 12 months and less than 45 ml/min/1.73m2 at inclusion
You will not qualify if you...
- Blood potassium (P-K) 5.6 or higher
- For the first ten participants: eGFR less than 20 ml/min/1.73m2 or projected decline to less than 10 ml/min/1.73m2 during the 36-week study
- For others: eGFR less than 10 ml/min/1.73m2 or projected decline to less than 10 ml/min/1.73m2 during the 36-week study
- Ongoing or planned dialysis
- Systolic blood pressure less than 90 mmHg
- Uncontrolled hypertension
- Severe liver impairment (Child-Pugh C)
- History of or planned heart transplant or left ventricular assist device
- Unwillingness to use effective contraception, pregnancy, or breastfeeding
- Previous allergic reaction to mineralocorticoid receptor antagonists or potassium binders
- Current treatment with lithium, cyclosporine, tacrolimus, NSAIDs, trimethoprim, strong CYP3A inhibitors or inducers
- QT interval (QTc(f)) 550 msec or longer, history of medication-related QT prolongation, or congenital long QT syndrome
- Uncontrolled arrhythmia
- Acute cardiac hospitalization or procedure within four weeks before inclusion
- Not suitable due to severe or terminal illness or expected survival less than 12 months
- Prior participation in this trial or participation in another trial not approved for co-enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology, Danderyd Hospital, Karolinska Institutet
Stockholm, Sweden
Actively Recruiting
Research Team
C
Carl Haggård, MD, PhD
CONTACT
K
Krister Lindmark, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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