Multiple Myeloma Clinical Trial
Official title:
Prevention of Left Ventricular Dysfunction With Enalapril and Carvedilol in Patients Submitted to Intensive Chemotherapy for the Treatment of Malignant Hemopathies
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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