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RecruitingNCT06853951Updated Mar 3, 2025

Cardioprotection on Chemotherapy-Induced Cardiotoxicity

A Phase 3 interventional study of ACE Inhibitors and β -Blockers in Cardiotoxicity, sponsored by Ain Shams University. Recruiting at 2 sites in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 7 months after the study started (first participant enrolled Jul 2023, registered Feb 2025).
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Cardiotoxicity

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03

In context

Cardiotoxicity

262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.

This study's planned enrollment of 30 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.

Browse Cardiotoxicity studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willingness of the legal representative of research participant to participate in the study by giving "."
  • Ability to take oral medication.
  • Age 2-18 years at the time of diagnosis.

Exclusion criteria

Exclusion Criteria:

  • Documented allergy to cardioprotective medications
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    ACEIs

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

    Drug: ACE Inhibitors

  • Active comparator
    β-blockers

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

    Drug: β -Blockers

Interventions

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

    Also known as: Captopril

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

    Also known as: Carvedilol

06

What researchers measure

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    he LVEF will be measure by 2D Echocardiography at baseline and at the end of Induction Phase (42 Days)

    Time frame: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06853951
Responsible party
keristin nazir (Teaching Assistant, Ain Shams University) — Principal investigator
First posted
Mar 3, 2025
Start date
Jul 18, 2023
Primary completion
Mar 30, 2025 (estimated)
Completion
Jul 18, 2025 (estimated)
Last update
Mar 3, 2025

Study contacts

Christen Said
Contact
keristin.nazir21@pharma.asu.edu.eg
+201093942389
Manal Hamed El-Hamamsy, Prof
principal investigator · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: ACE inhibitors · Carvedilol

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