Status:
COMPLETED
Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Fullcro s.r.l.
Conditions:
Heart Failure, Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiat...
Detailed Description
Heart failure (HF) is a significant burden for public health, affecting more than 63 million people worldwide and expected to increase as the population ages; in Italy, the estimated prevalence of HF ...
Eligibility Criteria
Inclusion
- Age equal or above 18 years old at the initiation of treatment with dapagliflozin
- Participant received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) in accordance with the approved local dapagliflozin product label, i.e. with an ejection fraction of 40 percent or less
- Signed and dated informed cconsent obtained prior to enrollment into the study
Exclusion
- Participant is enrolled less than 14 days or more than 45 days following the initiation of treatment with dapagliflozin
- Prior treatment with dapagliflozin or other treatment with a medicine of the same drug class (sodium-glucose co-transporter-2 - or SGLT2 - inhibitors)
- Initiation of dapagliflozin outside of the approved local dapagliflozin product label for HFrEF
- Diagnosis of Type 1 Diabetes
Key Trial Info
Start Date :
April 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT05250011
Start Date
April 19 2022
End Date
April 15 2024
Last Update
March 28 2025
Active Locations (11)
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1
Research Site
Brescia, BS, Italy, 25123
2
Research Site
Catanzaro, CZ, Italy, 88100
3
Research Site
Foggia, FG, Italy, 71122
4
Research Site
Florence, FI, Italy, 50100