Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF) — EVOLUTION-HF  

Heart Failure Clinical Trial

Official title: Early Treatment of Heart Failure: a Non-interventional Observational Study of Patients With Heart Failure and Initiated on Dapagliflozin in Portugal

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. EVOLUTION-HF will help obtaining relevant insights from clinical practice through the analysis of detailed data on heart failure symptoms/severity for patients receiving dapagliflozin in real-world setting. Study aims are to describe the characteristics of patients newly prescribed dapagliflozin for the treatment of HFrEF, to provide early insights into real-world dapagliflozin treatment patterns, and to describe patients-reported outcomes, medication adherence and work productivity losses in these patients. This observational, longitudinal cohort study will include patients with a physician diagnosis of HFrEF who are initiated on dapagliflozin in clinical practice. The study will include 2 cohorts of patients: one fully retrospective and one prospective cohort, in which patient-reported outcomes (PROs) including quality of life will be collected ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05465213
• Study type: Observational
• Source: AstraZeneca
• Status: Active, not recruiting
• Start date: November 28, 2022
• Completion date: December 31, 2023