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Observational study on dapagliflozin use in heart failure patients in Germany

Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)

Observational AstraZeneca · NCT06336330

This study looks at how well dapagliflozin works for people with heart failure in Germany and how it affects their daily lives and health care needs.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations47 sites (Aachen and 46 other locations)
Trial IDNCT06336330 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the usage of dapagliflozin in patients diagnosed with heart failure in Germany. It focuses on treatment patterns, symptoms of heart failure, and their effects on patients' quality of life and healthcare utilization. The study will include patients who have started treatment with dapagliflozin, regardless of their ejection fraction status, and will assess their health outcomes over time. By analyzing this data, the study seeks to provide insights into the effectiveness of dapagliflozin in everyday clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have initiated treatment with dapagliflozin for symptomatic chronic heart failure.

Not a fit: Patients who have previously been treated with dapagliflozin or other SGLT2 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of dapagliflozin's impact on heart failure management and improve patient outcomes.

How similar studies have performed: Other studies have shown positive outcomes with dapagliflozin in heart failure management, indicating that this approach is supported by existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Aachen and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart DiseasesCardiovascular DiseasesHeart FailureHeart Failure with preserved ejection fractionHeart Failure with mildly reduced ejection fractionHeart Failure with Reduced Ejection FractionDapagliflozinReal-World
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.