Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
Status: Recruiting
Location: See all (48) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
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Aachen
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Alsfeld
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Bamberg
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Bechhofen
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Bergisch Gladbach
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Berlin
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Berlin
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Brilon
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Bruchsal
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Chemnitz
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Dinslaken
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Erfurt
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Erfurt
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Essen
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Frankenthal
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Gera
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Hamburg
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Hamburg
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Hamburg
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Hoppegarten
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Kaiserslautern
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Kitzingen
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Ludwigsburg
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Ludwigshafen Am Rhein
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M Hldorf
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Markkleeberg
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Meiningen
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Münster
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Naumburg
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Nuremberg
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Oschersleben
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Papenburg
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WITHDRAWN
Passau
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Pirna
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Potsdam
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Querfurt
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Ratingen
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Rostock
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Schleswig
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Schwäbisch Hall
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Schwandorf In Bayern
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Siegen
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Steinfurt
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Stollberg
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Straubing
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Stuttgart
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Ulm
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Wermsdorf
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-04-25
Estimated Completion Date:2026-12-31
Participants
Target number of participants:1000
Treatments
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.
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.
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.