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Cardioprotection on Chemotherapy-Induced Cardiotoxicity

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06853951
Enrollment
30
Registered
2025-03-03
Start date
2023-07-18
Completion date
2025-07-18
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity

Brief summary

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

0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.

0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Arm 1 Patients will receive ACEIs oral tablets during Induction Phase by either a caregiver or caring nurse. Arm 2 Patients will receive β-blockers oral tablets during Induction Phase by either a caregiver or caring nurse.

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Left Ventricular Ejection Fraction (LVEF)LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)he LVEF will be measure by 2D Echocardiography at baseline and at the end of Induction Phase (42 Days)

Countries

Egypt

Contacts

Primary ContactChristen Said
keristin.nazir21@pharma.asu.edu.eg+201093942389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026