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

Last updated: April 3, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Vascular Diseases

Heart Failure

Treatment

N/A

Clinical Study ID

NCT06336330
D1699R00050
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years as of study index date; the study index date is date of initiation oftreatment with dapagliflozin

  • Patient received/receiving treatment with dapagliflozin in accordance with the localdapagliflozin product label for symptomatic chronic heart failure (HF) and attimepoint 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

Exclusion Criteria:

  • Patient should not be enrolled if he/she is less than 14 days or more than 90 daysfollowing 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 investigationalmedical 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

Study Design

Total Participants: 1000
Study Start date:
April 25, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Research Site

    Aachen, 52062
    Germany

    Active - Recruiting

  • Research Site

    Alsfeld, 36304
    Germany

    Active - Recruiting

  • Research Site

    Bamberg, 96049
    Germany

    Active - Recruiting

  • Research Site

    Bechhofen, 66894
    Germany

    Active - Recruiting

  • Research Site

    Bergisch Gladbach, 51465
    Germany

    Active - Recruiting

  • Research Site

    Berlin, 12489
    Germany

    Active - Recruiting

  • Research Site

    Brilon, 59929
    Germany

    Active - Recruiting

  • Research Site

    Bruchsal, 76646
    Germany

    Active - Recruiting

  • Research Site

    Chemnitz, 09113
    Germany

    Active - Recruiting

  • Research Site

    Dinslaken, 46535
    Germany

    Active - Recruiting

  • Research Site

    Erfurt, 99084
    Germany

    Active - Recruiting

  • Research Site

    Essen, 45128
    Germany

    Active - Recruiting

  • Research Site

    Frankenthal, 67227
    Germany

    Active - Recruiting

  • Research Site

    Gera, 07551
    Germany

    Active - Recruiting

  • Research Site

    Hamburg, 22459
    Germany

    Active - Recruiting

  • Research Site

    Hoppegarten, 15366
    Germany

    Active - Recruiting

  • Research Site

    Kaiserslautern, 67655
    Germany

    Active - Recruiting

  • Research Site

    Kitzingen, 97318
    Germany

    Active - Recruiting

  • Research Site

    Ludwigsburg, 71634
    Germany

    Active - Recruiting

  • Research Site

    Ludwigshafen am Rhein, 67071
    Germany

    Active - Recruiting

  • Research Site

    M Hldorf, 84453
    Germany

    Active - Recruiting

  • Research Site

    M Nster, 48149
    Germany

    Active - Recruiting

  • Research Site

    Markkleeberg, 4416
    Germany

    Active - Recruiting

  • Research Site

    Meiningen, 98617
    Germany

    Active - Recruiting

  • Research Site

    Muhldorf, 84453
    Germany

    Site Not Available

  • Research Site

    Munster, 48149
    Germany

    Site Not Available

  • Research Site

    Mühldorf, 84453
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Site Not Available

  • Research Site

    N Rnberg, 90402
    Germany

    Active - Recruiting

  • Research Site

    Naumburg, 6618
    Germany

    Active - Recruiting

  • Research Site

    Nurnberg, 90402
    Germany

    Site Not Available

  • Research Site

    Nürnberg, 90402
    Germany

    Site Not Available

  • Research Site

    Oschersleben, 39387
    Germany

    Active - Recruiting

  • Research Site

    Papenburg, 26871
    Germany

    Active - Recruiting

  • Research Site

    Passau, 94032
    Germany

    Site Not Available

  • Research Site

    Pirna, 1796
    Germany

    Active - Recruiting

  • Research Site

    Potsdam, 14471
    Germany

    Active - Recruiting

  • Research Site

    Querfurt, 06268
    Germany

    Active - Recruiting

  • Research Site

    Rostock, 18059
    Germany

    Active - Recruiting

  • Research Site

    Schleswig, 24837
    Germany

    Active - Recruiting

  • Research Site

    Schw Bisch Hall, 74523
    Germany

    Active - Recruiting

  • Research Site

    Schwabisch Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Schwandorf, 92421
    Germany

    Active - Recruiting

  • Research Site

    Schwäbisch Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Siegen, 57072
    Germany

    Active - Recruiting

  • Research Site

    Steinfurt, 48565
    Germany

    Active - Recruiting

  • Research Site

    Stollberg, 09366
    Germany

    Active - Recruiting

  • Research Site

    Straubing, 94315
    Germany

    Active - Recruiting

  • Research Site

    Stuttgart, 70178
    Germany

    Active - Recruiting

  • Research Site

    Ulm, 89073
    Germany

    Active - Recruiting

  • Research Site

    Wermsdorf, 04779
    Germany

    Active - Recruiting

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