BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE for Premature ventricular contractions | PVC-induced cardiomyopathy

Inclusion criteria

• {"criterion_text":"- 18 ≤ Age ≤ 85\n- PVC burden ≥ to 10% regardless of current or preexisting antiarrhythmic drug intake (for instance, a patient under betablocker therapy because of his PVCs or hypertension can be included)\n- Asymptomatic status\n- Normal (>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman\n- Patients that can’t undergo MRI study\n- De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)\n- The physician already decided that the patient requires drug initiation or escalation;\n- Ischemic cardiomyopathy requiring revascularization (PCI or surgery)\n- History of LV dysfunction\n- Participation in another research involving the human person\n- Patient under legal protection\n- Non affiliation to a social security scheme"}

Primary endpoints

• {"endpoint_text":"- the development of LV dysfunction (PVC‐iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF <50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).","definition_or_measurement_approach":"Defined as a 15% relative LVEF decrease and/or a LVEF <50% within 2 years following randomization, measured on cardiac magnetic resonance imaging (cMRI) or transthoracic echocardiography (TTE) if cMRI not possible."}

Secondary endpoints

• {"endpoint_text":"- Other efficacy endpoints","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mean PVC burden during the whole follow‐up (M6, M12, M18 and at M24)","definition_or_measurement_approach":"Mean PVC burden assessed at months 6, 12, 18 and 24."}
• {"endpoint_text":"- Percentage of patients with a PVC burden <10% during the second year following randomization (and time to obtain a PVC burden <10%)","definition_or_measurement_approach":"Proportion of patients with PVC burden <10% during year 2 post-randomization and time-to-event for achieving PVC burden <10%."}
• {"endpoint_text":"- LVEF variation (from baseline to M24)","definition_or_measurement_approach":"Change in left ventricular ejection fraction from baseline to month 24 (cMRI or TTE)."}
• {"endpoint_text":"- LV volumes variation (end‐diastolic and systolic volumes) from baseline to M24","definition_or_measurement_approach":"Change in LV end-diastolic and end-systolic volumes from baseline to month 24 (imaging)."}
• {"endpoint_text":"- Global Longitudinal Strain (GLS) variation from baseline to M24","definition_or_measurement_approach":"Change in GLS from baseline to month 24 (echocardiography/strain imaging)."}
• {"endpoint_text":"- Cumulative incidence of patients decreasing their GLS >15% from baseline to M24","definition_or_measurement_approach":"Cumulative incidence of >15% reduction in GLS between baseline and month 24."}
• {"endpoint_text":"- Nt‐ProBNP relative variation from baseline to M24","definition_or_measurement_approach":"Relative change in NT-proBNP levels from baseline to month 24."}
• {"endpoint_text":"- Exercise capacity on treadmill (Watts, Mets, MVO2) and NYHA at baseline and M24","definition_or_measurement_approach":"Treadmill exercise parameters (Watts, METs, MVO2) and NYHA class evaluated at baseline and month 24."}
• {"endpoint_text":"- Quality of life will be assessed with SF‐36 (Short Form 36) scale administered for both arms at inclusion, at M12 and at M24.","definition_or_measurement_approach":"SF-36 administered at inclusion, month 12 and month 24 to assess quality of life."}
• {"endpoint_text":"- Safety endpoints:  Death from any cause  Cardiovascular cause of death  Hospitalization for an adverse event  The nature, frequency, severity and outcome of adverse events (AE) and serious adverse events (SAE) within follow‐up (that may be linked or not to antiarrhythmic drugs (AAD) or ablation procedure)","definition_or_measurement_approach":"Safety assessments include all-cause death, CV death, hospitalizations for AEs, and recording of nature/frequency/severity/outcome of AEs and SAEs during follow-up; events may be linked to AADs or ablation."}

France

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

14

Number Of Sites

31

Number Of Participants

298

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France