Heart FailureEVOLUTION-HFNCT05465213
Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF)
An observational study of Heart Failure, run by AstraZeneca at 8 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 283 participants
- Where
- 8 sitesPortugal
- Study dates
- 28 Nov 2022to 24 Jun 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 with registered hospital diagnosis of HF who have received treatment with dapagliflozin for HFrEF will be eligible for enrolment by physicians from both outpatient and inpatient settings. In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enrol the patient into the study. To help ensure this, patients cannot be enrolled <30 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 30 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrolment onto the study. Data on other parameters may be obtained at the date of initiation of dapagliflozin by extracting this information retrospectively from medical charts.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Portugal8 sites
Research Site
Almada
Research Site
Amadora
Research Site
Coimbra
Research Site
Lisbon
Research Site
Penafiel
Research Site
Porto
Research Site
Setúbal
Research Site
Vila Real
About this study
Official title: Early Treatment of Heart Failure: a Non-interventional Observational Study of Patients With Heart Failure and Initiated on Dapagliflozin in Portugal
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.
Read the 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
- Keywords
- Heart Failure, Heart Failure with Reduced Ejection Fraction, HFrEF, Dapagliflozin, Real-world
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to dapagliflozin treatment discontinuation
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
Proportion of reasons for dapagliflozin treatment discontinuation
Proportion of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will 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 to another HF medication other than dapagliflozin.
Measured: Baseline to 12 months
Percentage of dapagliflozin treatment changes
The percentage of participants who switch to another HF medication other than dapagliflozin.
Measured: Baseline to 12 months
Number of dapagliflozin treatment discontinuation
The number of participants who discontinued treatment with dapagliflozin.
Measured: Baseline to 12 months
Percentage of dapagliflozin treatment discontinuation
The percentage of participants who discontinued treatment with dapagliflozin.
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 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
Percentage of other heart failure treatment initiation
The percentage of participants who initiate new heart failure medication other than dapagliflozin.
Measured: Baseline to 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
Percentage of other heart failure treatment dosage changes
The percentage of participants with dosage changes for heart failure medication other than dapagliflozin.
Measured: Baseline to 12 months
Number of other heart failure treatment discontinuation
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Measured: Baseline to 12 months
Percentage of other heart failure treatment discontinuation
The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Measured: Baseline to 12 months
Time to glucose lowering medication discontinuation
Time from initiation of glucose lowering medication until the time at which participants discontinued treatment with that medication.
Measured: Baseline to 12 months
Number of glucose lowering medication initiation
The number of participants who initiate new glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Percentage of glucose lowering medication initiation
The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Number of glucose lowering medication dosage changes
The number of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Percentage of glucose lowering medication dosage changes
The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Number of glucose lowering medication discontinuation
The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Percentage of glucose lowering medication discontinuation
The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Measured: Baseline to 12 months
Secondary outcomes (3)
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.
Only applicable to Prospective cohort.
Measured: Measured at 3, 6 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 behaviours occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence. The MARS-5 has been shown to be reliable and valid across a variety of health conditions, including cardiovascular and pulmonary diseases.
Only applicable to Prospective cohort.
Measured: Measured at 3, 6 and 12 months
Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
The WPAI is a validated instrument to measure impairments in paid and unpaid work and activities. It measures absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness) as well as the impairments in unpaid activity because of health problems during the past seven days. It has been validated to quantify work impairments for numerous diseases such as asthma, psoriasis, irritable bowel syndrome, and Crohn's disease, but has not yet been validated for use in heart failure participants. Scores will be derived from the overall work impairment at each timepoint and then changes of from baseline will be reported.
Only applicable to Prospective cohort.
Measured: Measured at 3, 6 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 posted19 Jul 2022
- Study start28 Nov 2022
- Primary completion24 Jun 2024
- Study completion24 Jun 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465213
- Sponsor's protocol ID
- D1699R00036
- Acronym
- EVOLUTION-HF
- Status last verified
- May 2025
- First submitted
- 28 Jun 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 6 Jun 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 of Patients With Heart Failure and Initiated on Dapagliflozin in Portugal
- ClinicalTrials.gov ID
- NCT05465213
- Acronym / sponsor ID
- EVOLUTION-HF / D1699R00036
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Heart Failure with Reduced Ejection Fraction, HFrEF, Dapagliflozin, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 19 Jul 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; 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with registered hospital diagnosis of HF who have received treatment with dapagliflozin for HFrEF will be eligible for enrolment by physicians from both outpatient and inpatient settings. In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enrol the patient into the study. To help ensure this, patients cannot be enrolled <30 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 30 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrolment onto the study. Data on other parameters may be obtained at the date of initiation of dapagliflozin by extracting this information retrospectively from medical charts.
Key inclusion criteria (5 listed)
- 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 enrollment in the study (only applicable for the prospective cohort, informed consent waiver will be requested for retrospective cohort)
Key exclusion criteria (4 listed)
- 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
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
Time to dapagliflozin treatment discontinuation
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.
Proportion of reasons for dapagliflozin treatment discontinuation
Time frame: Baseline to 12 months
Proportion of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will 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 to another HF medication other than dapagliflozin.
Percentage of dapagliflozin treatment changes
Time frame: Baseline to 12 months
The percentage of participants who switch to another HF medication other than dapagliflozin.
Number of dapagliflozin treatment discontinuation
Time frame: Baseline to 12 months
The number of participants who discontinued treatment with dapagliflozin.
Percentage of dapagliflozin treatment discontinuation
Time frame: Baseline to 12 months
The percentage of participants who discontinued treatment with dapagliflozin.
Time to other HF medication discontinuation
Time frame: Baseline to 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 initiation
Time frame: Baseline to 12 months
The number of participants who initiate new heart failure medication other than dapagliflozin.
Percentage of other heart failure treatment initiation
Time frame: Baseline to 12 months
The percentage of participants who initiate new heart failure medication other than dapagliflozin.
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.
Percentage of other heart failure treatment dosage changes
Time frame: Baseline to 12 months
The percentage of participants with dosage changes for heart failure medication other than dapagliflozin.
Number of other heart failure treatment discontinuation
Time frame: Baseline to 12 months
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Percentage of other heart failure treatment discontinuation
Time frame: Baseline to 12 months
The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Time to glucose lowering medication discontinuation
Time frame: Baseline to 12 months
Time from initiation of glucose lowering medication until the time at which participants discontinued treatment with that medication.
Number of glucose lowering medication initiation
Time frame: Baseline to 12 months
The number of participants who initiate new glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication initiation
Time frame: Baseline to 12 months
The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.
Number of glucose lowering medication dosage changes
Time frame: Baseline to 12 months
The number of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication dosage changes
Time frame: Baseline to 12 months
The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Number of glucose lowering medication discontinuation
Time frame: Baseline to 12 months
The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication discontinuation
Time frame: Baseline to 12 months
The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
3 secondary outcomes
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Measured at 3, 6 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Time frame: Measured at 3, 6 and 12 months
Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
Time frame: Measured at 3, 6 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 6 Jun 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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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.
8 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 8 sites in Portugal.
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 5 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Portugal. 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?
Time to dapagliflozin treatment discontinuation (time frame: Baseline to 12 months). The study lists 21 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 6 Jun 2025.