Clinical trial · Interventional
Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia
NCT03389724CI-TRIAL-00062046completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prevention and early detection of chemotherapy-induced cardiotoxicity in children with bone tumors and Acute Myeloid Leukemia by giving capoten
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia in Children | — | UNRESOLVED | — |
| Bone Tumor | Bone Neoplasm | ALIAS | 0.90 |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capoten® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group capoten (Intervention arm)
- description
- Patients will receive prophylactic ACE-I(Capoten®) at day 1 of initiation of chemotherapy and is to be continued for 1 year after the end of treatment. Patients will remain on this arm until they experience any of the study primary or secondary end-point where they will be off-study and will receive cardiotoxicity treatment independently.
- interventionNames
- Drug: Capoten®
- type
- NO_INTERVENTION
- label
- Group standard treatment (Control arm)
- description
- Patients will not receive ACE-I as prophylaxis, and will be monitored and evaluated for first signs of cardiotoxicity based on the above mentioned end-points.
Primary outcomes (3)
- measure
- To determine the effect of ACE-I in preventing chemotherapy-related cardiotoxicity using both investigation techniques: Troponin I level and cardiac imaging ( TTE, TDI, STE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All Acute Myeloid Leukemia and Bone Tumors patients (Osteosarcoma and Ewing's Sarcoma) who didn't receive chemotherapy will be included in the study. * Written Informed Consent from parents/guardian Exclusion Criteria: * Patients who received chemotherapy before starting of the study * Patients with history of cardiac impairment, (existing or congenital heart disease). * Patients who show intolerance or contra-indications to ACE-I. * Patients developing acute (\< 2 weeks) cardiotoxicity after the first high-dose chemotherapy (HDC) course.
References
Publications (0)
Data not yet available
No reference posted for this study.