Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece
EVOLUTION-HF
Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - GREECE)
1 other identifier
observational
257
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedStudy Start
First participant enrolled
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2024
CompletedNovember 24, 2025
October 1, 2025
1.9 years
November 23, 2022
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Baseline characteristics (demographic and clinical)
To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction
Baseline to 12 months
Time to discontinuation of dapagliflozin
Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.
Baseline to 12 months
Number of reasons for dapagliflozin treatment discontinuation
Number of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will be extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.
Baseline to 12 months
Number of dapagliflozin treatment changes
The number of participants who switch from dapagliflozin to another Heart Failure medication.
Baseline to 12 months
Time to other HF medication discontinuation
Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
Baseline 12 months
Number of other heart failure treatment dosage changes
The number of participants with dosage changes for heart failure medication other than dapagliflozin.
Baseline to 12 months
Number of other heart failure treatment initiation
The number of participants who initiate new heart failure medication other than dapagliflozin.
Baseline to 12 months
Secondary Outcomes (2)
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Measured at enrollment and 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Measured at enrollment, 3, 6, 9 and 12 months
Eligibility Criteria
Patients who have received treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction will be eligible for enrolment by physicians from outpatient and inpatient settings. Eligible patients will be selected after they have been identified in paper or electronic medical records by the participating investigator. Consecutive patients prescribed dapagliflozin should be identified by the investigator and, unless failing to meet the inclusion and exclusion criteria, should be invited to participate. Patients will only be enrolled after they have given consent to participate in the study. In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enroll the patient into the study. To help ensure this, at least 14 days must have elapsed (but no more than 60 days) from the date of initiation of dapagliflozin before a patient can be enrolled.
You may qualify if:
- Age ≥18 years as of study index date; the study index date is the date of initiation of treatment with dapagliflozin
- Patient received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction in accordance with the local dapagliflozin product label
- Signed and dated informed consent prior to enrolment in the study
You may not qualify if:
- Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin
- Prior treatment with dapagliflozin or other Sodium Glucose co-transporter 2 inhibitor treatment
- Initiation of dapagliflozin outside of local Heart Failure label
- Diagnosis of Type 1 diabetes prior to enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Alexandroupoli, 68100, Greece
Research Site
Athens, 11526, Greece
Research Site
Athens, 11527, Greece
Research Site
Athens, 11528, Greece
Research Site
Athens, 12462, Greece
Research Site
Athens, 14233, Greece
Research Site
Athens, 17674, Greece
Research Site
Chania, 73300, Greece
Research Site
Heraklion, 71409, Greece
Research Site
Ioannina, 45445, Greece
Research Site
Ioannina, 45500, Greece
Research Site
Pátrai, 26504, Greece
Research Site
Thessaloniki, 54636, Greece
Research Site
Thessaloniki, 54642, Greece
Research Site
Thessaloniki, 56429, Greece
Research Site
Thessaloniki, 57010, Greece
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 2, 2022
Study Start
December 28, 2022
Primary Completion
December 3, 2024
Study Completion
December 3, 2024
Last Updated
November 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.