Actively Recruiting

Phase 3
Age: 1Year - 18Years
All Genders
ID06853951

The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia

Led by Ain Shams University · Updated on 2025-03-03

30

Participants Needed

2

Research Sites

15 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how cardioprotective medications affect chemotherapy-induced heart damage in children with acute leukemia. The study compares two types of heart-protecting drugs, Angiotensin-converting enzyme (ACE) inhibitors and beta-blockers, to understand their impact on heart function during cancer treatment. The study focuses on children aged 2 to 18 years and measures heart health using echocardiography. Participants receive either ACE inhibitors or beta-blockers orally, dosed by caregivers or nurses. ACE inhibitors are given at 0.3 mg per kilogram every 8 hours, while beta-blockers are administered at 0.05 mg per kilogram every 12 hours. The treatment is monitored from the start until the end of the chemotherapy induction phase, which lasts 42 days. During the study, children's heart function is assessed using 2D echocardiography to measure left ventricular ejection fraction (LVEF) at the beginning and end of the induction phase. Researchers track changes in heart performance to determine how well each medication protects the heart from chemotherapy effects. The total participation period covers these 42 days, with close monitoring of heart health and medication adherence.

CONDITIONS

Brief Title

Cardioprotection on Chemotherapy-Induced Cardiotoxicity

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness of the legal representative of research participant to participate in the study by giving informed consent
  • Ability to take oral medication
  • Age 2-18 years at the time of diagnosis
Not Eligible

You will not qualify if you...

  • Documented allergy to cardioprotective medications

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 42 days

Participants receive either ACE inhibitors or β-blockers to evaluate their protective effect on chemotherapy-induced cardiotoxicity.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 2 locations

1

Faculty of Pharmacy, Ain Shams University

Cairo, Egypt, 11566

Actively Recruiting

2

Faculty of Pharmacy, Ain Shams University

Cairo, Egypt

Actively Recruiting

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Research Team

C

Christen Said

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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