NCT05465213Completed
Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF)
Early Treatment of Heart Failure: a Non-interventional Observational Study of Patients With Heart Failure and Initiated on Dapagliflozin in Portugal
Source: ClinicalTrials.gov · Last updated 6 Jun 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
- 283 (actual)
- First submitted
- 28 Jun 2022
- Start date
- 28 Nov 2022
- Primary completion date
- 24 Jun 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Heart failure
- NCT number
- NCT05465213
What you commit to
- Study type: Observational
- Participants enrolled: 283
- From 28 Nov 2022 to the primary completion date, 24 Jun 2024
- 8 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 30 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:
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Almada | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Amadora | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Penafiel | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Setúbal | Portugal | Unknown status |
| - Coordinator of this site? Confirm its status | Vila Real | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.