Cardioprotection on Chemotherapy-Induced Cardiotoxicity

NCT06853951 | Recruiting Phase 3 DMC

• 1 other identifier: 315
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cardiotoxicity

Outcome Measures

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)

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

Study Arms (2)

ACEIs

ACTIVE COMPARATOR

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

Drug: ACE Inhibitors

β-blockers

ACTIVE COMPARATOR

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

Drug: β -Blockers

Interventions

ACE Inhibitors DRUG

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

Also known as: Captopril

ACEIs

β -Blockers DRUG

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

Also known as: Carvedilol

β-blockers

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Documented allergy to cardioprotective medications

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Faculty of Pharmacy, Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Faculty of Pharmacy, Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Angiotensin-Converting Enzyme Inhibitors; Captopril; Carvedilol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Manal Hamed El-Hamamsy, Prof

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christen Said

CONTACT

+201093942389; keristin.nazir21@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 3, 2025
• Study Start: July 18, 2023
• Primary Completion: March 30, 2025
• Study Completion: July 18, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)