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Bisoprolol Administration to Prevent Anthracycline-induced Cardiotoxicity

NCT05175066 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-03

No results posted yet for this study

Summary

Anthracyclines are one of the most well-known and effective drugs used to treat malignancies.The most important limiting factor in the use of this drug is its cardiac toxicity which includes cardiomyopathy and congestive heart failure. Bisoprlol is a β1-specific β-blocker that can reduce cardiac overload and also have anti-inflammatory antioxidant effects and can reduce reactive oxygen metabolites so it can be used as a cardioprotective agent in patients with a high risk of heart failure. To the best of our knowledge, no study has been performed to evaluate the prophylactic effect of bisoprolol solely in patients under chemotherapy with anthracyclines. This study is aimed to evaluate the cardioprotective role of bisoprolol in patients with non-metastatic breast cancer receiving doxorubicin, by measuring global longitudinal strain before and after treatment.

Conditions

  • Cardiomyopathies
  • Chemotherapy Effect
  • Diastolic Dysfunction
  • Systolic Dysfunction

Interventions

DRUG

Bisoprolol

For patients who were candidates to start therapy with anthracycline, bisoprolol was administrated as explained before to determine the effect of this drug on the reduction of anthracycline-induced cardiomyopathy.

DRUG

Placebo

Tablets with similar shape and size and color to bisoprolol were given to the patients whom undergone chemotherapy with anthracyclines to compare the effects between two groups.

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2021-10-07
Completion
2021-12-02

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

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 NCT05175066 on ClinicalTrials.gov