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Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: Heart Diseases, Cardiovascular Diseases, Heart Failure

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (47)

Aachen, Germany
Alsfeld, Germany
Bamberg, Germany
Bechhofen, Germany
Bergisch Gladbach, Germany
Berlin, Germany
Berlin, Germany
Brilon, Germany
Bruchsal, Germany
Chemnitz, Germany
Dinslaken, Germany
Erfurt, Germany
Erfurt, Germany
Essen, Germany
Frankenthal, Germany
Gera, Germany
Hamburg, Germany
Hamburg, Germany
Hamburg, Germany
Hoppegarten, Germany
Kaiserslautern, Germany
Kitzingen, Germany
Ludwigsburg, Germany
Ludwigshafen am Rhein, Germany
M Hldorf, Germany
Markkleeberg, Germany
Meiningen, Germany
Münster, Germany
Naumburg, Germany
Nuremberg, Germany
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