Heart DiseasesEvolutionHF-DENCT06336330
Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany
An observational study of Heart Diseases and Cardiovascular Diseases, run by AstraZeneca at 47 sites in Germany.
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 to 130 years
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, Heart Failure
- How many people
- 831 participants
- Where
- 47 sitesGermany
- Study dates
- 25 Apr 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received treatment with dapagliflozin for HF since 14-90 day before entering the study will be eligible for enrolment by either primary or secondary care healthcare professionals from outpatient settings. All treatment decisions (i.e., dose and duration of treatment) will be at the discretion of the patient's healthcare provider. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 days and ≤90 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. Patients will only be enrolled after they have given consent to participate in the study. It is at the discretion of the physician whether or not to initiate patients on treatment with dapagliflozin and enrol them in the study.
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 in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with:
- preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%)
- OR reduced ejection fraction (HFrEF EF ≤40%)
- Patient is enrolled within 14 to 90 days following initiation of dapagliflozin
- Signed and dated informed consent prior to enrolment in the study
Who cannot join
- Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
- Prior treatment with dapagliflozin or other SGLT2i treatment
- Initiation of dapagliflozin outside of the local HF label
- Diagnosis of Type 1 diabetes prior to enrolment
- Current or planned participation in a clinical trial using an investigational medical product for treating HF
- Patient is involved in the planning and/or conduction of the study
- Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Germany47 sites
Research Site
Aachen, 52062
Research Site
Alsfeld, 36304
Research Site
Bamberg, 96049
Research Site
Bechhofen, 66894
Research Site
Bergisch Gladbach, 51465
Research Site
Berlin, 12489
Research Site
Berlin, 12555
Research Site
Brilon, 59929
Research Site
Bruchsal, 76646
Research Site
Chemnitz, 09113
Research Site
Dinslaken, 46535
Research Site
Erfurt, 99084
Research Site
Erfurt, 99097
Research Site
Essen, 45128
Research Site
Frankenthal, 67227
Research Site
Gera, 07551
Research Site
Hamburg, 20095
Research Site
Hamburg, 22087
Research Site
Hamburg, 22459
Research Site
Hoppegarten, 15366
Research Site
Kaiserslautern, 67655
Research Site
Kitzingen, 97318
Research Site
Ludwigsburg, 71634
Research Site
Ludwigshafen am Rhein, 67071
Research Site
M Hldorf, 84453
Research Site
Markkleeberg, 4416
Research Site
Meiningen, 98617
Research Site
Münster, 48149
Research Site
Naumburg, 6618
Research Site
Nuremberg, 90402
Research Site
Oschersleben, 39387
Research Site
Papenburg, 26871
Research Site
Pirna, 01796
Research Site
Potsdam, 14471
Research Site
Querfurt, 06268
Research Site
Ratingen, 40882
Research Site
Rostock, 18059
Research Site
Schleswig, 24837
Research Site
Schwäbisch Hall, 74523
Research Site
Schwandorf in Bayern, 92421
Research Site
Siegen, 57072
Research Site
Steinfurt, 48565
Research Site
Stollberg, 09366
Research Site
Straubing, 94315
Research Site
Stuttgart, 70178
Research Site
Ulm, 89073
Research Site
Wermsdorf, 04779
About this study
Official title: Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
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). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany.
- Conditions
- Heart Diseases, Cardiovascular Diseases, Heart Failure
- Keywords
- Heart Failure with preserved ejection fraction (HFpEF), Heart Failure with mildly reduced ejection fraction (HFmrEF), Heart Failure with Reduced Ejection Fraction (HFrEF), Dapagliflozin, Real-World
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, 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 |
|---|---|---|
| HFpEF | Adult patients with preserved ejection fraction (HFpEF; EF≥50%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. | |
| HFmrEF | Adult patients with mildly reduced ejection fraction (HFmrEF; EF 41-49%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. | |
| HFrEF | Adult patients with reduced ejection fraction (HFrEF; EF ≤40%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation of dapagliflozin
Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason (from the perspective of the prescriber).
Measured: Baseline to 12 months
Reasons for discontinuation of dapagliflozin
Reasons for discontinuation (from the perspective of the prescriber) of patients initiated on dapagliflozin for HF will be described.
Measured: Baseline to 12 months
Dose changes of dapagliflozin
The number of participants with doses changes for dapagliflozin
Measured: Baseline to 12 months
Number of patients with dapagliflozin treatment interruptions
The number of participants who discontinue treatment with dapagliflozin.
Measured: Baseline to 12 month
Treatment switches from dapagliflozin to other SGLT2i
The number of participants who switch from dapagliflozin to another SGLT2i (Sodium-glucose cotransporter-2 inhibitor) treatment for HF.
Measured: Baseline to 12 months
Time to other heart failure treatment 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
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 discontinuation
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
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
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
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
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. Several summary scores may be calculated including: Total Symptom score (measuring symptom frequency and symptom burden), Physical limitation score (measuring limitations in common physical activities), Clinical Summary score (measure of physical limitations and total symptoms), and an Overall Summary score (measure of physical limitations, total symptoms, HRQoL, and social limitations). Summary scores will be examined at each assessment point during follow-up.
Measured: Measured at 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 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.
Measured: Measured at 3, 6, 9 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.
Measured: Measured at 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 posted28 Mar 2024
- Study start25 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336330
- Sponsor's protocol ID
- D1699R00050
- Acronym
- EvolutionHF-DE
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2024
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
- ClinicalTrials.gov ID
- NCT06336330
- Acronym / sponsor ID
- EvolutionHF-DE / D1699R00050
- Conditions
- Heart Diseases, Cardiovascular Diseases, Heart Failure
- Keywords
- Heart Failure with preserved ejection fraction (HFpEF), Heart Failure with mildly reduced ejection fraction (HFmrEF), Heart Failure with Reduced Ejection Fraction (HFrEF), Dapagliflozin, Real-World
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 831 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Mar 2024 (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). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | –Adult patients with preserved ejection fraction (HFpEF; EF≥50%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. |
| HFmrEF | – | –Adult patients with mildly reduced ejection fraction (HFmrEF; EF 41-49%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. |
| HFrEF | – | –Adult patients with reduced ejection fraction (HFrEF; EF ≤40%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received treatment with dapagliflozin for HF since 14-90 day before entering the study will be eligible for enrolment by either primary or secondary care healthcare professionals from outpatient settings. All treatment decisions (i.e., dose and duration of treatment) will be at the discretion of the patient's healthcare provider. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 days and ≤90 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. Patients will only be enrolled after they have given consent to participate in the study. It is at the discretion of the physician whether or not to initiate patients on treatment with dapagliflozin and enrol them in the study.
Key inclusion criteria (6 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 in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with:
- Patient is enrolled within 14 to 90 days following initiation of dapagliflozin
- Signed and dated informed consent prior to enrolment in the study
Key exclusion criteria (7 listed)
- Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
- Prior treatment with dapagliflozin or other SGLT2i treatment
- Initiation of dapagliflozin outside of the local HF label
- Diagnosis of Type 1 diabetes prior to enrolment
- Current or planned participation in a clinical trial using an investigational medical product for treating HF
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 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 (from the perspective of the prescriber).
Reasons for discontinuation of dapagliflozin
Time frame: Baseline to 12 months
Reasons for discontinuation (from the perspective of the prescriber) of patients initiated on dapagliflozin for HF will be described.
Dose changes of dapagliflozin
Time frame: Baseline to 12 months
The number of participants with doses changes for dapagliflozin
Number of patients with dapagliflozin treatment interruptions
Time frame: Baseline to 12 month
The number of participants who discontinue treatment with dapagliflozin.
Treatment switches from dapagliflozin to other SGLT2i
Time frame: Baseline to 12 months
The number of participants who switch from dapagliflozin to another SGLT2i (Sodium-glucose cotransporter-2 inhibitor) treatment for HF.
Time to other heart failure treatment 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.
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 discontinuation
Time frame: Baseline to 12 months
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
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.
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.
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.
3 secondary outcomes
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Time frame: Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
Time frame: Measured at 3, 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
47 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 Diseases and Cardiovascular Diseases, run by AstraZeneca at 47 sites in Germany.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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 discontinuation of dapagliflozin (time frame: Baseline to 12 months). The study lists 12 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 13 Jul 2026.