Prevention of anthracycline-induced cardiotoxicity: a multicentre randomizedtrial comparing two therapeutic strategies.

• Conditions: Anthracycline-­-induced cardiotoxicity; MedDRA version: 14.1Level: PTClassification code 10008444Term: Chemotherapy cardiotoxicity attenuationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002248-26-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-13
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age equal to or greater than 18years; 2. Patients with any of the following diagnosis of cancer: acute leukemia, Non-­-Hodgkin lymphoma, Hodgkin’s lymphoma, breast cancer, sarcoma; 3. Indication for first-­-and second-­-line therapy with anthracyclines; 4. Serum creatinine<177µmol/L (2mg/100mL); 5. Systolic blood pressure>100mmHg and <170mmHg; 6. LVEF>50%; 7. Written informed consent;
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1. History or clinical/instrumental evidences of heart failure and/or ischemic heart disease; 2. Plasma supranormal concentrations of cardiac troponin (i.e. higher than the cut-­-off recommended by the manufacturer); 3. Systolic blood pressure<100mmHg; 4. Heart rate<50 bpm; 5. Prior malignancy requiring chemotherapy; 6. Uncontrolled hypertension defined as systolic blood pressure>170mmHg; 7. Treatment with ACEi or BB within 4 weeks prior to study start; 8. Known intolerance to enalapril, except for cough; 9. Planned treatment with dexaroxane; 10. Participation in another experimental drug trial within 4 weeks prior to study start; 11. Non-­-co-­-operative behaviour or suspected poor compliance; 12. Pregnancy or breast feeding; 13. Scheduled mediastinal radiotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified