Anthracycline--induced cardiotoxicity MedDRA version: 14.1 Level: PT Classification code 10008444 Term: Chemotherapy cardiotoxicity attenuation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: NAPRILENE*28CPR 5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: ENALAPRIL MALEATE
CAS Number: 76095-16-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 creatinine100mmHg and 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
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 pressure170mmHg; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess whether enalapril started concomitantly to anthracycline therapy can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of cardiac injury after chemotherapy.;Secondary Objective: Secondary objectives will be the reduction of admissions to hospital for cardiovascular causes; deaths for cardiovascular causes. Differences between the two study groups in the following continuous variables will be also assessed: (1) cardiac structural and functional variables by echocardiography (in all patients), by Magnetic Resonance Imaging (in a subgroup); (2)biomarkers such as NT--pro BNP, PTX- -3. Quality of life of patients will be also assessed.;Primary end point(s): Time to first elevation of cTn concentration above the cut--off recommended by the manufacturer, over a follow up of 1 year from the end of CT.;Timepoint(s) of evaluation of this end point: 1 year, starting from the end of the last cycle of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes over time in a. left ventricular function; b. NT--proBNP, cTn; c. PTX3.;Timepoint(s) of evaluation of this end point: 1 year, starting from the end of the last cycle of chemotherapy. | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
ISTITUTO EUROPEO DI ONCOLOGIA
Outcome results
None listed