Menu
Recruiting NCT06853951

Cardioprotection on Chemotherapy-Induced Cardiotoxicity

Phase III Interventional Cardiotoxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACE Inhibitors, β -Blockers.
Who it may be relevant to
Registry conditions: Cardiotoxicity. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.

Detailed description

The goal of this interventional study is to evaluate the protective impact of Angiotensin-converting enzyme (ACE) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. The impact is measured by evaluation of left ventricular ejection fraction (LVEF) by 2D echocardiography at baseline and at the end of Induction phase (42 days).

Interventions

  • Drug ACE Inhibitors
    0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.
  • Drug β -Blockers
    0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse.

Primary outcome measures

  • Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Documented allergy to cardioprotective medications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 2 centers
  • Faculty of Pharmacy, Ain Shams University — Cairo
  • Faculty of Pharmacy, Ain Shams University — Cairo

Identifiers

NCT: NCT06853951 · 315

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗