Trials / Completed

CompletedNCT01110824

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

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 90 (actual)

Sponsor: Hospital Clinic of Barcelona · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	Enalapril and carvedilol	Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID

Timeline

Start date: 2008-04-01
Primary completion: 2011-12-01
Completion: 2012-03-01
First posted: 2010-04-27
Last updated: 2013-11-15

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT01110824. Inclusion in this directory is not an endorsement.