Cardioprotection on Chemotherapy-Induced Cardiotoxicity

NCT ID: NCT06853951

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-18

Study Completion Date

2025-07-18

Brief Summary

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

Detailed Description

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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).

Conditions

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Cardiotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ACEIs

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

Group Type ACTIVE_COMPARATOR

ACE Inhibitors

Intervention Type DRUG

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

β-blockers

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

Group Type ACTIVE_COMPARATOR

β -Blockers

Intervention Type DRUG

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

Interventions

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ACE Inhibitors

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

Intervention Type DRUG

β -Blockers

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

Intervention Type DRUG

Other Intervention Names

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Captopril Carvedilol

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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keristin nazir

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hamed El-Hamamsy, Prof

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Pharmacy, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Faculty of Pharmacy, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Christen Said

Role: CONTACT

+201093942389

Facility Contacts

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Aml Elkhouly, Assoc. Prof

Role: primary

0201060355448

Other Identifiers

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315

Identifier Type: -

Identifier Source: org_study_id

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