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

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2012年9月13日最近更新: 2014年2月10日

试验速览

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•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

•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

发起方