A Multicenter Randomized Double-Blind Parallel Group Placebo-Controlled Trial to Evaluate the Effect of InHospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who Have Been Stabilized During Hospitalization for Acute Heart Failure

Brief description of study

This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart is not pumping enough blood with each heartbeat. Dapagliflozin is a drug that has been approved by the US Food and Drug Administration (FDA) to improve blood sugar control in patients with type 2 diabetes and to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and either cardiovascular disease or cardiovascular risk factors. Dapagliflozin has also been approved by the FDA to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure regardless of whether they have diabetes. It has not, however, been studied in patients hospitalized for acute heart failure. The use of dapagliflozin in this study is investigational. An investigational use is one that is not approved by the FDA. This trial will determine if it is safe and beneficial to start dapagliflozin during hospital admission for acute heart failure.


Clinical Study Identifier: s20-00277
ClinicalTrials.gov Identifier: NCT04363697
Principal Investigator: Cezar S Staniloae.
Other Investigators: Manuel E. Morlote, Tajinderpal Saraon, Randal Ian Goldberg.


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