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NCT Number: NCT06853951

Cardioprotection on Chemotherapy-Induced Cardiotoxicity

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

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACE Inhibitors

Drug

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

Other names: Captopril

β -Blockers

Drug

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

Other names: Carvedilol

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christen Said

CONTACT

[email protected]

+201093942389

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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