Cardioprotection on Chemotherapy-Induced Cardiotoxicity

February 25, 2025 updated by: keristin nazir, Ain Shams University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Pharmacy, Ain Shams University
      • Cairo, Egypt, 11566
        • Recruiting
        • Faculty of Pharmacy, Ain Shams University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACEIs
0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.
Drug: ACE Inhibitors
0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.
Other Names:
  • Captopril
Active Comparator: β-blockers
0.05 mg/kg/dose every 12 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.
Other Names:
  • Carvedilol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Manal Hamed El-Hamamsy, Prof, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

July 18, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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