Cardioprotection on Chemotherapy-Induced Cardiotoxicity

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Cardiotoxicity

Treatments: Drug: β -Blockers; Drug: ACE Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT06853951

315

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ACEIs

Active Comparator group

Description:

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

Treatment:

Drug: ACE Inhibitors

β-blockers

Active Comparator group

Description:

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

Treatment:

Drug: β -Blockers