Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT07029503
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07029503
Study Brief:
Protocol Section:
NCT07029503