Language: BG BG
← Back to results
Active (not recruiting) NCT06336330

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

Conditions: Heart Diseases Cardiovascular Diseases Heart Failure

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Who can participate
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
Germany (47)
Research Site
Aachen
Research Site
Alsfeld
Research Site
Bamberg
Research Site
Bechhofen
Research Site
Bergisch Gladbach
Research Site
Berlin
Research Site
Berlin
Research Site
Brilon
Research Site
Bruchsal
Research Site
Chemnitz
Research Site
Dinslaken
Research Site
Erfurt
Research Site
Erfurt
Research Site
Essen
Research Site
Frankenthal
Research Site
Gera
Research Site
Hamburg
Research Site
Hamburg
Research Site
Hamburg
Research Site
Hoppegarten
Research Site
Kaiserslautern
Research Site
Kitzingen
Research Site
Ludwigsburg
Research Site
Ludwigshafen am Rhein
Research Site
M Hldorf
Research Site
Markkleeberg
Research Site
Meiningen
Research Site
Münster
Research Site
Naumburg
Research Site
Nuremberg
Research Site
Oschersleben
Research Site
Papenburg
Research Site
Pirna
Research Site
Potsdam
Research Site
Querfurt
Research Site
Ratingen
Research Site
Rostock
Research Site
Schleswig
Research Site
Schwäbisch Hall
Research Site
Schwandorf in Bayern
Research Site
Siegen
Research Site
Steinfurt
Research Site
Stollberg
Research Site
Straubing
Research Site
Stuttgart
Research Site
Ulm
Research Site
Wermsdorf
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
25.04.2024
Completion date
31.12.2026
Registry ID
NCT06336330
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.