Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany
EvolutionHF-DE
Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
1 other identifier
observational
831
1 country
47
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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Typical duration for all trials
47 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
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 20, 2026
April 1, 2026
2.7 years
March 22, 2024
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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).
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.
Baseline to 12 months
Dose changes of dapagliflozin
The number of participants with doses changes for dapagliflozin
Baseline to 12 months
Number of patients with dapagliflozin treatment interruptions
The number of participants who discontinue treatment with dapagliflozin.
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.
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.
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
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 discontinuation
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Baseline to 12 months
Number of glucose lowering medication initiation
The number of participants who initiate new glucose lowering medication other than dapagliflozin.
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.
Baseline to 12 months
Number of glucose lowering medication discontinuation
The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Baseline to 12 months
Secondary Outcomes (3)
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
Measured at 3, 6, 9 and 12 months
Other Outcomes (3)
The absolute change from baseline in occurrence of depressions in patients initiated on dapagliflozin for HF as captured by the Patient Health Questionnaire-9 (PHQ-9)
Measured at 3, 6, 9 and 12 months
Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation
Measured at 3, 6, 9 and 12 months
Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation
Measured at 3, 6, 9 and 12 months
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (47)
Research Site
Aachen, 52062, Germany
Research Site
Alsfeld, 36304, Germany
Research Site
Bamberg, 96049, Germany
Research Site
Bechhofen, 66894, Germany
Research Site
Bergisch Gladbach, 51465, Germany
Research Site
Berlin, 12489, Germany
Research Site
Berlin, 12555, Germany
Research Site
Brilon, 59929, Germany
Research Site
Bruchsal, 76646, Germany
Research Site
Chemnitz, 09113, Germany
Research Site
Dinslaken, 46535, Germany
Research Site
Erfurt, 99084, Germany
Research Site
Erfurt, 99097, Germany
Research Site
Essen, 45128, Germany
Research Site
Frankenthal, 67227, Germany
Research Site
Gera, 07551, Germany
Research Site
Hamburg, 20095, Germany
Research Site
Hamburg, 22087, Germany
Research Site
Hamburg, 22459, Germany
Research Site
Hoppegarten, 15366, Germany
Research Site
Kaiserslautern, 67655, Germany
Research Site
Kitzingen, 97318, Germany
Research Site
Ludwigsburg, 71634, Germany
Research Site
Ludwigshafen am Rhein, 67071, Germany
Research Site
M Hldorf, 84453, Germany
Research Site
Markkleeberg, 4416, Germany
Research Site
Meiningen, 98617, Germany
Research Site
Münster, 48149, Germany
Research Site
Naumburg, 6618, Germany
Research Site
Nuremberg, 90402, Germany
Research Site
Oschersleben, 39387, Germany
Research Site
Papenburg, 26871, Germany
Research Site
Pirna, 01796, Germany
Research Site
Potsdam, 14471, Germany
Research Site
Querfurt, 06268, Germany
Research Site
Ratingen, 40882, Germany
Research Site
Rostock, 18059, Germany
Research Site
Schleswig, 24837, Germany
Research Site
Schwandorf in Bayern, 92421, Germany
Research Site
Schwäbisch Hall, 74523, Germany
Research Site
Siegen, 57072, Germany
Research Site
Steinfurt, 48565, Germany
Research Site
Stollberg, 09366, Germany
Research Site
Straubing, 94315, Germany
Research Site
Stuttgart, 70178, Germany
Research Site
Ulm, 89073, Germany
Research Site
Wermsdorf, 04779, Germany
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
March 28, 2024
Study Start
April 25, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
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.