Prevention of Anthracycline-induced Cardiotoxicity

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Enalapril; Enalaprilat

Criteria

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.