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The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACEIs | Active Comparator | 0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse. |
|
| β-blockers | Active Comparator | 0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE Inhibitors | Drug | 0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christen Said | Contact | +201093942389 | keristin.nazir21@pharma.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Manal Hamed El-Hamamsy, Prof | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Ain Shams University | Recruiting | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D002216 | Captopril |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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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.
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| β -Blockers | Drug | 0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse. |
|
|
| Faculty of Pharmacy, Ain Shams University | Recruiting | Cairo | Egypt |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D020164 | Chemical Actions and Uses |
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |