A Phase 3 interventional study of Enalapril and carvedilol in Acute Myeloid Leukemia, Precursor-cell Lymphoblastic Leukemia-Lymphoma and Lymphoid Neoplasm, sponsored by Hospital Clinic of Barcelona. Completed at 2 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-11-15.
Sponsored by Hospital Clinic of Barcelona · Phase 3, Interventional, and Prevention
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.
The prognosis of patients with hematological malignancies has greatly improved in the last years with the use of new chemotherapeutic drugs and regimens at the cost of significant adverse events such as cardiac toxicity. Asymptomatic left ventricular systolic dysfunction limits the specific treatment of the patients and their long-term survival, since a significant proportion of them will relapse within 5 years after front-line therapy and will require further salvage treatment, including hematopoietic stem-cell transplantation in most instances.
Angiotensin-converting enzyme inhibitors (ACEIs) have showed to have preventive effects against chemotherapy-induced cardiotoxicity in animal models, and in patients with early cardiotoxicity. Carvedilol prevent free radical release, mitochondrial dysfunction, apoptosis, and dilated cardiomyopathy in animals treated with anthracyclines, and have shown promising results in preventing chemotherapy-induced left ventricular dysfunction in patients.
As demonstrated in post-infarction patients, the combined treatment with an ACEI and carvedilol could have additive effects to prevent LV dysfunction in patients with hematological malignancies at high risk of cardiac toxicity. Therefore, we designed the OVERCOME (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies) study, a prospective, randomized trial to evaluate the combined effect of enalapril and carvedilol on the prevention of left ventricular dysfunction in patients with malignant hemopathies undergoing intensive chemotherapy.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 90 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Enalapril 2.5 to 10 mg BID plus Carvedilol 6.25 to 25 mg BID
Drug: Enalapril and carvedilol
Control arm without intervention
Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography and by cardiac magnetic resonance imaging (CMR).
Time frame: 6 months after randomization
Incidence of death, heart failure or LV systolic disfunction (LVEF<45%)
Time frame: 6 months after randomization
Assessment of genetic polymorphisms involved in chemotherapy-induced cardiotoxicity
Time frame: Baseline
Prognostic value for cardiac toxicity of troponin I and BNP
Time frame: up to 3 months
Right and left ventricular volumes measured by CMR
Time frame: 6 months after randomization
Subgroup analysis by diagnosis (acute leukemia vs. other malignant hemopathies submitted to autologous peripheral blood stem cell transplantation), and positive biomarkers (TnI, BNP).
Time frame: 6 months after randomization
Incidence of an absolute decrease in LVEF>10 percent units associated with a decline below its normal limit of 50%
Time frame: 6 months after randomization
Serious adverse events
Time frame: 6 months after randomization
the incidence of LV dysfunction as assessed by the measurement of the LV strain, and of diastolic dysfunction measured by echo-Doppler
Time frame: 6 months after randomization
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona