Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines

• Status: Active, not recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

As the cancer-related prognosis improves thanks to recent advances in cancer-targeted therapies, the prognostic burden of chemotherapy-related complications - including cardiotoxicity - is increasingly recognised. So far, the evidence supporting pharmacological preventive strategies in cardio-oncology has been inconsistent and conflicting, and there is a clear need for well-designed trials with novel interventions. In this study, by using cardiac magnetic resonance, the investigators want to assess if a commonly used beta-blocker with a unique pharmacological profile, i.e. nebivolol, can prevent cardiac dysfunction in patients with breast cancer or diffuse large B-cell lymphoma undergoing chemotherapy with anthracyclines.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Giulio Stefanini
• Collaborator: Agenzia Italiana del Farmaco
• Treatments: Nebivolol

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