NCT06336330Active, not recruiting
Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany
Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 831 (actual)
- First submitted
- 22 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Heart failure
- NCT number
- NCT06336330
What you commit to
- Study type: Observational
- Participants enrolled: 831
- From Apr 2024 to the primary completion date, Dec 2026
- 43 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with dapagliflozin or other SGLT2i treatment
- Diagnosis of Type 1 diabetes prior to enrolment
Other illness
- Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC
Other
- Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
- Initiation of dapagliflozin outside of the local HF label
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.