ICOS-ONE - Prevention of Anthracycline-induced Cardiotoxicity: a Multicentre Randomized Trial Comparing Two Therapeutic Strategies.

IEO S701/412

Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF). ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients.

2012-12-01

2019-12-01

2023-12-01

Active (not recruiting)

Early phase I

268

Inclusion Criteria: 1. Patients with diagnosis of cancer and indication for first- and second-line therapy with anthracyclines 2. Age ≥18years 3. Serum creatinine\<177µmol/L(2mg/100mL) 4. Systolic blood pressure ≥100 mmHg and ≤170 mmHg 5. Left ventricular ejection fraction (VEF) \>50% 6. Written informed consent. 7. Life expectancy of at least 12 months Exclusion Criteria: 1. Patients with history or clinical/instrumental evidences of heart failure 2. Patients with history or clinical/instrumental evidences of ischemic heart disease; 3. Patients with blood troponin levels higher than the cut-off suggested by the manufacturer before starting cancer CT; 4. Systolic blood pressure\<100 mmHg; 5. Heart rate\<50 bpm; 6. Prior malignancy requiring potentially cardiotoxic chemotherapy (e.g. anthracyclines, trastuzumab..);; 7. Uncontrolled hypertension defined as systolic blood pressure\>170 mmHg; 8. Treatment with ACEi, ARB or BB within 4 weeks prior to study start; 9. Known intolerance to enalapril, except for cough; 10. Planned treatment with dexrazoxane; 11. Participation in another experimental drug trial within 4 weeks prior to study start; 12. Non-cooperative behaviour or suspected poor compliance; 13. Psychiatric disorders or conditions that might impair the ability to give informed consent; 14. Pregnancy or breast feeding; 15. Scheduled mediastinal radiotherapy.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 268, 'type': 'ESTIMATED'}}

2023-06-28