Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom. (EVOLUTION-HF)

AstraZeneca

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT05188144

D169CR00001

Details and patient eligibility

About

Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL

Enrollment: 237 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin
• Patient received/receiving treatment with dapagliflozin for HFrEF (EF ≤40%) 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 SGLT2i treatment
• Initiation of dapagliflozin outside of local HF label
• Diagnosis of Type 1 diabetes prior to enrolment