CardiotoxicityPhase 3NCT06853951
Cardioprotection on Chemotherapy-Induced Cardiotoxicity
A Phase 3 study testing ACE Inhibitors and β -Blockers in people with Cardiotoxicity, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cardiotoxicity
- What is being tested?
- ACE Inhibitors and β -Blockers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Jul 2023to 18 Jul 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Documented allergy to cardioprotective medications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Pharmacy, Ain Shams University
Cairo, 11566
Aml Elkhouly, Assoc. Prof, 0201060355448, Amal.Elkhouly@pharma.asu.edu.eg
- Recruiting
Faculty of Pharmacy, Ain Shams University
Cairo
About this study
Official title: 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.
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).
- Conditions
- Cardiotoxicity
- Being tested
- ACE Inhibitors, β -Blockers
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE InhibitorsDrug
Also called Captopril
0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.
β -BlockersDrug
Also called Carvedilol
0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse.
| Study group | Role | What they receive |
|---|---|---|
| ACEIs | Active comparator | 0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse. Receives: Drug: ACE Inhibitors |
| β-blockers | Active comparator | 0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse Receives: Drug: β -Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start18 Jul 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion18 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, keristin nazir, Ain Shams University
- Investigators
- Manal Hamed El-Hamamsy, Prof, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853951
- Sponsor's protocol ID
- 315
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia
- ClinicalTrials.gov ID
- NCT06853951
- Acronym / sponsor ID
- 315
- Conditions
- Cardiotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 18 Jul 2025 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACEIs | Active comparator | Drug: ACE Inhibitors0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse. |
| β-blockers | Active comparator | Drug: β -Blockers0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Documented allergy to cardioprotective medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE InhibitorsAlso: Captopril0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse. | Drug | ACEIs |
| β -BlockersAlso: Carvedilol0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse. | Drug | β-blockers |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal Hamed El-Hamamsy, Prof principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACE Inhibitors and β -Blockers in people with Cardiotoxicity, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christen Said (+201093942389, keristin.nazir21@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.