Clinical trial · Interventional
Prevention of Left Ventricular Dysfunction During Chemotherapy
Prevention of Left Ventricular Dysfunction With Enalapril and Carvedilol in Patients Submitted to Intensive Chemotherapy for the Treatment of Malignant Hemopathies
NCT01110824CI-TRIAL-00012646OVERCOMEcompletedPhase 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)
The investigators' objective is to assess the efficacy of the combined treatment with enalapril and carvedilol in the prevention of left ventricular systolic dysfunction in patients with hematological malignancies submitted to intensive chemotherapy with potential cardiotoxicity. The hypothesis is that these drugs administered during chemotherapy may prevent left ventricular systolic dysfunction.
Conditions
Conditions (6)
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Autologous Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Lymphoid Neoplasm | Lymphoid Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Precursor-cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enalapril and carvedilol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enalapril and carvedilol
- description
- Enalapril 2.5 to 10 mg BID plus Carvedilol 6.25 to 25 mg BID
- interventionNames
- Drug: Enalapril and carvedilol
- type
- NO_INTERVENTION
- label
- Control
- description
- Control arm without intervention
Primary outcomes (1)
- measure
- Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography and by cardiac magnetic resonance imaging (CMR).
- timeFrame
- 6 months after randomization
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients 18-70 years old * Sinus rhythm * Normal LVEF (\>=50%) * Patients recently diagnosed of acute leukemia to be submitted to intensive chemotherapy or * Patients with other hemopathies submitted to autologous peripheral blood stem cell transplantation * Signed informed consent Exclusion Criteria: * Congestive heart failure * LVEF\<50% * Coronary artery disease, * significant valvulopathy or myocardiopathy * Renal failure (MDRD\<30) * Liver failure * Ongoing or expected need to be treated with angiotensin-converting enzyme inhibitors (ACE-i),angiotensin II receptor blockers (ARB) or beta-blockers * Prior allergy to ACEI or ARB * Systolic blood pressure \<90 mmHg * Asthma * Auriculoventricular (AV) block or sinus bradycardia (HR\<60 bpm) * Persistent atrial fibrillation * Need to be treated with Class I antiarrhythmic drugs * Pregnancy * Inability or unwillingness to give unformed consent
References
Publications (2)
- BACKGROUNDBosch X, Esteve J, Sitges M, de Caralt TM, Domenech A, Ortiz JT, Monzo M, Morales-Ruiz M, Perea RJ, Rovira M. Prevention of chemotherapy-induced left ventricular dysfunction with enalapril and carvedilol: rationale and design of the OVERCOME trial. J Card Fail. 2011 Aug;17(8):643-8. doi: 10.1016/j.cardfail.2011.03.008. Epub 2011 May 6. PMID 21807325
- RESULTBosch X, Rovira M, Sitges M, Domenech A, Ortiz-Perez JT, de Caralt TM, Morales-Ruiz M, Perea RJ, Monzo M, Esteve J. Enalapril and carvedilol for preventing chemotherapy-induced left ventricular systolic dysfunction in patients with malignant hemopathies: the OVERCOME trial (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies). J Am Coll Cardiol. 2013 Jun 11;61(23):2355-62. doi: 10.1016/j.jacc.2013.02.072. Epub 2013 Apr 10. PMID 23583763