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

NCT05465213

CompletedN/A

Sponsor: AstraZeneca

Conditions: Heart Failure

Countries: Portugal

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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:

  * Retrospective study: their dapagliflozin initiation was between 1st of March 2021 and 31st of October 2021.
  * Prospective study: their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrollment onto the study
* Signed and dated informed consent prior to enrollment in the study (only applicable for the prospective cohort, informed consent waiver will be requested for retrospective cohort)

Exclusion Criteria:

* Patient is enrolled less than 30 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
Locations (8)
  • Almada, Portugal
  • Amadora, Portugal
  • Coimbra, Portugal
  • Lisbon, Portugal
  • Penafiel, Portugal
  • Porto, Portugal
  • Setúbal, Portugal
  • Vila Real, Portugal