Ongoing randomised controlled trials investigating cardioprotective therapy with ACEi, ARB and β-blockade to prevent anthracycline cardiotoxicity
| Study/registration | Patients | Treatment arms | Endpoints and follow-up | Estimated completion |
| ICOS-ONE: NCT01968200 | 268 (mixed cancers) | Enalapril started concomitantly with anthracycline versus selective prescription of enalapril following detection of elevated cTnI concentration during chemotherapy | Primary: cTnI elevation above laboratory threshold 1 year after anthracycline chemotherapy Secondary: hospital admission owing to cardiac causes 3 years after therapy | December 2017 |
| PROACT NCT03265574 | 170 (breast cancer) | Enalapril commenced prior to anthracycline versus standard care in patients receiving >300 mg/m2 epirubicin | Primary: cTnT release during epirubicin treatment Secondary: LVEF change on echocardiography 1 month after last epirubicin dose | September 2019 |
| Cardiac CARE ISRCTN24439460 | 168 (breast cancer) 56 high-risk patients will be randomised | Candesartan and carvedilol versus standard care in patients receiving >300 mg/m2 who exhibit high-risk hs cTnI concentration profiles during anthracycline treatment | Primary: change in LVEF (cardiac MRI) from baseline to 6 months after chemotherapy in randomised patients Secondary: change in LVEF from baseline to 6 months in non-randomised low-risk patients | November 2020 |
ACEi, ACE inhibition; ARB, angiotensin receptor blockade; cTnT, cardiac troponin T; hs cTnI, high-sensitivity cardiac troponin I; LVEF, left ventricular ejection fraction.