Prevention of Left Ventricular Dysfunction During Chemotherapy
OVERCOME
3 other identifiers
interventional
90
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 15, 2013
November 1, 2013
3.7 years
April 23, 2010
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography and by cardiac magnetic resonance imaging (CMR).
6 months after randomization
Secondary Outcomes (8)
Incidence of death, heart failure or LV systolic disfunction (LVEF<45%)
6 months after randomization
Assessment of genetic polymorphisms involved in chemotherapy-induced cardiotoxicity
Baseline
Prognostic value for cardiac toxicity of troponin I and BNP
up to 3 months
Right and left ventricular volumes measured by CMR
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).
6 months after randomization
- +3 more secondary outcomes
Study Arms (2)
Enalapril and carvedilol
EXPERIMENTALEnalapril 2.5 to 10 mg BID plus Carvedilol 6.25 to 25 mg BID
Control
NO INTERVENTIONControl arm without intervention
Interventions
Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID
Eligibility Criteria
You may qualify if:
- Adult patients 18-70 years old
- 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
You may not qualify if:
- Congestive heart failure
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Instituto de Salud Carlos IIIcollaborator
- European Unioncollaborator
Study Sites (2)
Hospital Clinic
Barcelona, Catalonia, 08035, Spain
Hospital Clinic
Barcelona, Catalonia, 08036, Spain
Related Publications (2)
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.
PMID: 21807325BACKGROUNDBosch 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.
PMID: 23583763RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xavier Bosch, M.D., PhD.
Hospital Clinic, University of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 27, 2010
Study Start
April 1, 2008
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
November 15, 2013
Record last verified: 2013-11