Prevention of Left Ventricular Dysfunction With Enalapril and Carvedilol in Patients Submitted to Intensive Chemotherapy for the Treatment of Malignant Hemopathies
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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography and and by cardiac magnetic resonance imaging (CMRI).
6-9 months after randomization
No
Xavier Bosch, M.D., PhD.
Study Chair
Hospital Clinic, University of Barcelona
Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios
OVERCOME
NCT01110824
April 2008
December 2011
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