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NCT05635331
Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Enrollment: 250
Sponsor: AstraZeneca
Location: Greece
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age ≥18 years as of study index date; the study index date is the date of initiation of treatment with dapagliflozinPatient received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction in accordance with the local dapagliflozin product labelSigned and dated informed consent prior to enrolment in the studyExclusion Criteria:Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozinPrior treatment with dapagliflozin or other Sodium Glucose co-transporter 2 inhibitor treatmentInitiation of dapagliflozin outside of local Heart Failure labelDiagnosis of Type 1 diabetes prior to enrolment
Source: ClinicalTrials.gov (NCT05635331). StuddyBuddy aggregates publicly available trial information.