Evaluation of the protective effect on the heart of a betablocker drug, nebivolol, in patients with breast cancer or diffuse B-cell lymphoma for which anthracyclinic chemotherapy has been planned

Phase 1

• Conditions: To prevent cardiotoxicity of chemotherapeutic agents (anthracyclines); MedDRA version: 20.1Level: PTClassification code 10008444Term: Chemotherapy cardiotoxicity attenuationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004618-24-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-14
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of betablocker nebivolol on heart function in patients treated with anthracyclines.;Secondary Objective: Imaging endpoints:<br>LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass. <br>Biomarker endpoints:<br>Serum troponin levels, serum BNP levels.<br>Clinical endpoints:<br>All-cause mortality, cardiovascular mortality, myocardial infarction, cerebrovascular events, and hospitalization for heart failure <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Imaging endpoints:<br>LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass. <br>Biomarker endpoints:<br>Serum troponin levels, serum BNP levels.<br>Clinical endpoints:<br>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