BISOPROLOL FUMARATE for Heart failure in remission

Inclusion criteria

• {"criterion_text":"- Adults aged ≥ 18 years"}
• {"criterion_text":"- Heart failure in remission, defined as heart failure with an improved ejection fraction to an LVEF above 50%, with normalized LV volumes, an NT-proBNP ≤ 250 pg/mL, normal functional capacity, and clinical stability"}
• {"criterion_text":"- Patients must receive at least 3 HF therapies (ACEi/ARB/ARNI, BB, and MRA or SGLT2i) for HF, consistent with international HF guidelines. Each therapy must have been titrated to the maximally tolerated dose, stable for at least 6 months prior to screening"}

Exclusion criteria

• {"criterion_text":"- Albuminuric chronic kidney disease"}
• {"criterion_text":"- Recent major cardiovascular events such as an acute coronary syndrome, CABG, stroke or TIA in the 90 days before screening"}
• {"criterion_text":"- Uncontrolled hypertension"}
• {"criterion_text":"- Atrial fibrillation or atrial flutter with a resting heart rate >110 beats per minute"}
• {"criterion_text":"- Patients with a cardiac resynchronization therapy device who have < 98% biventricular pacing during screening"}
• {"criterion_text":"- Any sustained ventricular arrythmias within 6 months prior to screening"}
• {"criterion_text":"- Any untreated valvular heart disease of moderate or greater severity during screening."}
• {"criterion_text":"- Presence of any other disease with a life expectancy of < 2 years."}
• {"criterion_text":"- Pregnant or lactating women."}

Primary endpoints

• {"endpoint_text":"- Left ventricular remodeling, measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of more than 20% from baseline","definition_or_measurement_approach":"Measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of >20% from baseline"}
• {"endpoint_text":"- NT-proBNP increase to more than 500 pg/mL","definition_or_measurement_approach":"NT-proBNP concentration measured; endpoint defined as increase to >500 pg/mL"}
• {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Death from any cause (time-to-event)"}

Secondary endpoints

• {"endpoint_text":"- Time to first occurrence of all-cause mortality or all-cause hospitalizations","definition_or_measurement_approach":"Time-to-event analysis for first occurrence of all-cause death or all-cause hospitalization"}
• {"endpoint_text":"- Change in KCCQ-12","definition_or_measurement_approach":"Change from baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score"}
• {"endpoint_text":"- Proportion of patients requiring HF treatment re-initiation or escalation (i.e., (re-)initation of at least one guideline-directed medical therapy or starting a loop diuretic)","definition_or_measurement_approach":"Proportion of patients who require re-initiation or escalation of HF therapy, defined as (re-)initiation of at least one guideline-directed medical therapy or start of a loop diuretic"}

Belgium

Earliest CTIS Part Ii Submission Date

14-10-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

27

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Ziekenhuis Oost Limburg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium