NCT05250011Completed
Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice
Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with dapagliflozin according to the approved HFrEF indication. The study is aimed at providing insights into real-world drug utilization and treatment patterns of dapagliflozin in the Italian HFrEF setting, as well as patient-reported outcomes including quality of life.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 252 (actual)
- First submitted
- 20 Jan 2022
- Start date
- 19 Apr 2022
- Primary completion date
- 15 Apr 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Heart failure
- NCT number
- NCT05250011
What you commit to
- Study type: Observational
- Participants enrolled: 252
- From 19 Apr 2022 to the primary completion date, 15 Apr 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant is enrolled less than 14 days or more than 45 days following the initiation of treatment with dapagliflozin
Other illness
- Diagnosis of Type 1 Diabetes
Lab values
- Prior treatment with dapagliflozin or other treatment with a medicine of the same drug class (sodium-glucose co-transporter-2 - or SGLT2 - inhibitors)
Other
- Initiation of dapagliflozin outside of the approved local dapagliflozin product label for HFrEF
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.