DACALY; A randomized, placebo-controlled, double-blinded Phase 2 trial of dapagliflozin for preventing treatment-associated cardiotoxicity in lymphoma
Novo Nordisk Foundation
Aalborg University Hospital
Anthracyclines, mainly doxorubicin, are used in treatment of lymphoma but cardiotoxicity is a serious complication. Anthracycline cardiotoxicity is dose-dependent and even patients exposed to low doses face a risk of congestive heart failure. Patients treated with anthracyclines have excellent survival rates, and the majority become long-term survivors, making prevention of late toxicities, compromising quality of life and life expectancy, critical. This nationwide, randomized, double-blinded, phase 2 clinical trial investigates tolerability and efficacy of dapagliflozin, a SGLT2 inhibitor approved for heart failure treatment, as a cardioprotective drug in this population. The study has a potential to improve prognosis and quality of life for patients exposed to anthracycline treatment. Should dapagliflozin improve early ultrasound measures of cardiotoxicity, the current study will serve as a basis for a larger phase 3 trial to confirm efficacy with heart failure as endpoint.
Research Projects (Max 10 MDKK) / Projects / Award