Prevention of Left Ventricular Dysfunction During Chemotherapy
NCT ID: NCT01110824
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2008-04-30
2012-03-31
Brief Summary
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The hypothesis is that these drugs administered during chemotherapy may prevent left ventricular systolic dysfunction.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enalapril and carvedilol
Enalapril 2.5 to 10 mg BID plus Carvedilol 6.25 to 25 mg BID
Enalapril and carvedilol
Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID
Control
Control arm without intervention
No interventions assigned to this group
Interventions
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Enalapril and carvedilol
Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
European Union
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Xavier Bosch
Dr.
Principal Investigators
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Xavier Bosch, M.D., PhD.
Role: STUDY_CHAIR
Hospital Clinic, University of Barcelona
Locations
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Hospital Clinic
Barcelona, Catalonia, Spain
Hospital Clinic
Barcelona, Catalonia, Spain
Countries
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References
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Bosch 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.
Bosch 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.
Other Identifiers
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2007-006604-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FIS EC07/90211
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OVERCOME
Identifier Type: -
Identifier Source: org_study_id