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NCT05188144Completed

Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom.

Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - UK)

Source: ClinicalTrials.gov · Last updated 25 Feb 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
237 (actual)
First submitted
9 Nov 2021
Start date
29 Nov 2021
Primary completion date
2 Mar 2024
Lead sponsor
AstraZeneca
NCT number
NCT05188144

What you commit to

  • Study type: Observational
  • Participants enrolled: 237
  • From 29 Nov 2021 to the primary completion date, 2 Mar 2024
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with dapagliflozin or other SGLT2i treatment
  • Diagnosis of Type 1 diabetes prior to enrolment

Other

  • Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin
  • Initiation of dapagliflozin outside of local HF label

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
BarnstapleUnited KingdomUnknown status
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BrightonUnited KingdomUnknown status
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CoventryUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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PortadownUnited KingdomUnknown status
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Port TalbotUnited KingdomUnknown status
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ReadingUnited KingdomUnknown status
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Stoke-on-TrentUnited KingdomUnknown status
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Coordinator of this site? Confirm its status
TruroUnited KingdomUnknown status
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Coordinator of this site? Confirm its status
Westcliff-on-SeaUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.