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New treatment option for HFrEF - Heart Failure With Reduced Ejection Fraction
Official title Swedish Cardiac And Renal Failure Study-1
ClinicalTrials.gov ID: NCT07029503
What this study is testing
What is Eplerenone?
Eplerenone is an investigational medicine, given as an once-daily, being studied as a potential treatment for hfref - heart failure with reduced ejection fraction.
Also referred to as Inspra®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%. The responsible investigator is allowed to order a new TTE at...
- 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...
You likely can't join if
- P-K ≥ 5.6
- For the first ten study participants: eGFR \< 20 ml/min/1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \< 10...
- Ongoing/planned dialysis
- Systolic blood pressure \< 90 mmHg
- Uncontrolled hypertension as judged by the investigator
- Severe hepatic impairment (Child-Pugh C)
See the full eligibility 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%. The responsible investigator is allowed to order a new TTE at their own discretion if clinically indicated - e.g. following the...
- 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...
- 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
- P-K ≥ 5.6
- For the first ten study participants: eGFR \< 20 ml/min/1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \< 10 ml/min/1.73m2 during the 36-week study period. The projected decline will...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.