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

NCT ID: NCT05465213

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 283 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2024-06-24

Brief 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.

Detailed 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

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Retrospective cohort

Patients who have initiated treatment with dapagliflozin for HFrEF between 1st of March 2021 and 31st of October 2021 (prior to study initiation date).

No interventions assigned to this group

Prospective Cohort

Patients who have started treatment with dapagliflozin for HFrEF from 1st April 2022 onwards. At least 30 days must have elapsed (but no more than 60 days) from first prescription of dapagliflozin before a patient can be enrolled.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Almada, , Portugal

Research Site

Amadora, , Portugal

Research Site

Coimbra, , Portugal

Research Site

Lisbon, , Portugal

Research Site

Penafiel, , Portugal

Research Site

Porto, , Portugal

Research Site

Setúbal, , Portugal

Research Site

Vila Real, , Portugal

Countries

Portugal

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1699R00036&attachmentIdentifier=cd2345e0-a715-40a8-aad7-bf5bf14de759&fileName=D1699R00036_Redacted_CSR_synopsis.pdf&versionIdentifier=

Redacted CSR synopsis

Other Identifiers

D1699R00036

Identifier Type: -

Identifier Source: org_study_id