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

NCT05728632 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nebivolol

Nebivolol, capsule, 5 mg once daily, for 12 months

DRUG

Placebo

Placebo, capsule, once daily, for 12 months

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Giulio Stefanini

    lead OTHER

Principal Investigators

  • Gianluigi Condorelli, MD,PhD,Prof · IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy

  • Giulio G Stefanini, MD,PhD,Prof · IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy

  • Carmelo Carlo-Stella, MD,Prof · IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728632 on ClinicalTrials.gov