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

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AstraZeneca

Status

Enrolling

Conditions

Cardiovascular Diseases
Heart Failure
Heart Diseases

Study type

Observational

Funder types

Industry

Identifiers

NCT06336330
D1699R00050

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 3 patient groups

HFpEF
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

36

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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