To prevent cardiotoxicity of chemotherapeutic agents (anthracyclines) MedDRA version: 20.1 Level: PT Classification code 10008444 Term: Chemotherapy cardiotoxicity attenuation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: NEBIVOLOLO DOC GENERICI - 5 MG COMPRESSE "" 28 COMPRESSE IN BLISTER PVDC/PVC/AL
Product Name: NEBIVOLOLO
Product Code: NEBIVOLOLO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Established histological diagnosis of BC or DLBCL 3. Planned first-line chemotherapy with anthracyclines 4. LVEF =55% (assessed by echocardiography) 5. Ability to provide informed consent 6. For women of childbearing potential a negative serum pregnancy is required before the inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Known intolerance/contraindications to betablocker therapy 2. Known hypersensitivity to nebivolol or any of the excipients 3. History of coronary artery disease 4. History of cardiomyopathy 5. History of heart failure 6. Ongoing treatment with betablockers for other indications 7. Heart rate <60 beats per minute 8. Arterial blood pressure <100/60 mmHg 9. Contraindications to undergo MRI (e.g., non compatible pacemakers or metallic prosthesis) 10. Pregnancy or lactation 11. Currently participating in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of betablocker nebivolol on heart function in patients treated with anthracyclines.;Secondary Objective: Imaging endpoints: LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass. Biomarker endpoints: Serum troponin levels, serum BNP levels. Clinical endpoints: All-cause mortality, cardiovascular mortality, myocardial infarction, cerebrovascular events, and hospitalization for heart failure ;Primary end point(s): Left ventricular ejection fraction (LVEF) reduction assessed by cardiac MRI at 12 months of follow-up. LVEF reduction is defined as the difference between LVEF at baseline and LVEF at 12 months follow-up.;Timepoint(s) of evaluation of this end point: 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Imaging endpoints: LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass. Biomarker endpoints: Serum troponin levels, serum BNP levels. Clinical endpoints: All-cause mortality, cardiovascular mortality, myocardial infarction, cerebrovascular events, and hospitalization for heart failure ;Timepoint(s) of evaluation of this end point: 30 days, 6 months, 12 months | — |
Countries
Italy
Contacts
Public ContactCRO
CD Pharma Group S.r.l.
Outcome results
None listed