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

NCT ID: NCT06336330

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 765 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Heart Diseases; Cardiovascular Diseases; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HFpEF

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.

No interventions assigned to this group

HFmrEF

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.

No interventions assigned to this group

HFrEF

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Aachen, , Germany

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Alsfeld, , Germany

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Bamberg, , Germany

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Bechhofen, , Germany

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Bergisch Gladbach, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Brilon, , Germany

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Bruchsal, , Germany

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Chemnitz, , Germany

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Dinslaken, , Germany

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Erfurt, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Frankenthal, , Germany

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Gera, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hoppegarten, , Germany

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Kaiserslautern, , Germany

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Kitzingen, , Germany

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Ludwigsburg, , Germany

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Ludwigshafen am Rhein, , Germany

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M Hldorf, , Germany

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Markkleeberg, , Germany

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Meiningen, , Germany

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Münster, , Germany

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Naumburg, , Germany

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Nuremberg, , Germany

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Oschersleben, , Germany

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Papenburg, , Germany

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Pirna, , Germany

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Potsdam, , Germany

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Querfurt, , Germany

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Ratingen, , Germany

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Rostock, , Germany

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Schleswig, , Germany

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Schwandorf in Bayern, , Germany

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Schwäbisch Hall, , Germany

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Siegen, , Germany

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Steinfurt, , Germany

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Stollberg, , Germany

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Straubing, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Wermsdorf, , Germany

Countries

Germany

Other Identifiers

D1699R00050

Identifier Type: -

Identifier Source: org_study_id