Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines (CONTROL)
Breast Cancer, Lymphoma, Large B-Cell, Diffuse, Cardiotoxicity
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring anthracycline chemotherapy, nebivolol, cardio-oncology, cancer therapy-related cardiovascular toxicity, cardiac magnetic resonance, primary prevention, cardioprotection, cardiotoxicity
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Established histologic diagnosis of breast cancer or diffuse large B-cell lymphoma Planned chemotherapy with anthracyclines left ventricular ejection fraction ≥55% (assessed by echocardiography) Ability to provide informed consent Exclusion Criteria: Known intolerance/contraindications to betablocker therapy History of coronary artery disease History of cardiomyopathy History of heart failure Ongoing treatment with betablockers for other indications Heart rate at baseline <60 beats per minute Arterial blood pressure at baseline <100/60 mmHg Contraindications to undergo cardiac magnetic resonance (e.g., non-compatible pacemakers or metallic prosthesis) Pregnancy or lactation Current participation to another study
Sites / Locations
- IRCCS Humanitas Research Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Nebivolol
Placebo
nebivolol, capsule, 5 mg once daily, for 12 months
placebo, capsule, once daily, for 12 months