Prevention of Left Ventricular Dysfunction During Chemotherapy

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Collaborators: European Union; Instituto de Salud Carlos III
• Treatments: Carvedilol; Enalapril; Enalaprilat

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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