Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece (EVOLUTION-HF)

AstraZeneca

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT05635331

D1699R00046

Details and patient eligibility

About

Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality. Dapagliflozin has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in May 2020 and November 2020 respectively, for HF with reduced ejection fraction (HFrEF). The overall aim of this study is to describe the characteristics of patients initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns as well as patient-reported outcomes (PROs) including quality of life.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years as of study index date; the study index date is the date of initiation of treatment with dapagliflozin
• Patient received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction in accordance with the local dapagliflozin product label
• Signed and dated informed consent prior to enrolment in the study

Exclusion criteria

• Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin
• Prior treatment with dapagliflozin or other Sodium Glucose co-transporter 2 inhibitor treatment
• Initiation of dapagliflozin outside of local Heart Failure label
• Diagnosis of Type 1 diabetes prior to enrolment