Heart FailureEVOLUTION-HFNCT05635331
Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece
An observational study of Heart Failure, run by AstraZeneca at 16 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 257 participants
- Where
- 16 sitesGreece
- Study dates
- 28 Dec 2022to 3 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Greece16 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Athens, 11528
Research Site
Athens, 12462
Research Site
Athens, 14233
Research Site
Athens, 17674
Research Site
Chania, 73300
Research Site
Heraklion, 71409
Research Site
Ioannina, 45445
Research Site
Ioannina, 45500
Research Site
Pátrai, 26504
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 54642
Research Site
Thessaloniki, 56429
Research Site
Thessaloniki, 57010
About this study
Official title: Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - GREECE)
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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Number of dapagliflozin treatment changes
The number of participants who switch from dapagliflozin to another Heart Failure medication.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Number of other heart failure treatment initiation
The number of participants who initiate new heart failure medication other than dapagliflozin.
Measured: Baseline to 12 months
Secondary outcomes (2)
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ is a 23-item questionnaire that quantifies physical limitations, self-efficacy, social interference and quality of life. Summary scores will be examined at each assessment point during follow-up. For each of the assessment periods, descriptive statistics for the observed value, change from baseline and the 95% two-sided confidence interval for the mean change will be presented. The proportions of participants with overall health status classified as poor, fair, good, and excellent will be examined at each assessment point. Additionally, the proportions of participants who experience clinically meaningful changes in overall health status: improvement (≥5 point increase), deterioration (≥5 point decrease), and stable (<5 point increase or decrease) will be examined at each assessment point.
Measured: Measured at enrollment and 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
The MARS-5 is five-item self-report adherence scale which assesses both intentional and non-intentional non-adherence. Respondents rate the frequency with which the five different medication-taking behaviors occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence.
Measured: Measured at enrollment, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start28 Dec 2022
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635331
- Sponsor's protocol ID
- D1699R00046
- Acronym
- EVOLUTION-HF
- Status last verified
- Oct 2025
- First submitted
- 23 Nov 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - GREECE)
- ClinicalTrials.gov ID
- NCT05635331
- Acronym / sponsor ID
- EVOLUTION-HF / D1699R00046
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline characteristics (demographic and clinical)
Time frame: Baseline to 12 months
To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction
Time to discontinuation of dapagliflozin
Time frame: Baseline to 12 months
Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.
Number of reasons for dapagliflozin treatment discontinuation
Time frame: Baseline to 12 months
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.
Number of dapagliflozin treatment changes
Time frame: Baseline to 12 months
The number of participants who switch from dapagliflozin to another Heart Failure medication.
Time to other HF medication discontinuation
Time frame: Baseline 12 months
Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
Number of other heart failure treatment dosage changes
Time frame: Baseline to 12 months
The number of participants with dosage changes for heart failure medication other than dapagliflozin.
Number of other heart failure treatment initiation
Time frame: Baseline to 12 months
The number of participants who initiate new heart failure medication other than dapagliflozin.
2 secondary outcomes
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Measured at enrollment and 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Time frame: Measured at enrollment, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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A Study of Bimagrumab in Participants With HFpEF
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by AstraZeneca at 16 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics (demographic and clinical) (time frame: Baseline to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.