Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice

Completed

• Conditions: Heart Failure, Reduced Ejection Fraction
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT05250011
• Lead Sponsor: AstraZeneca

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 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.

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 is 1-3% and the incidence rate 2-5 cases per 1000 persons per year. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality and impacts on patients' quality of life (QoL). Dapagliflozin is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors, approved for the treatment of Heart Failure with reduced Ejection Fraction (HFrEF). As with all new drugs introduced into clinical practice, there is a strong scientific interest in producing evidence from observational studies regarding the use of dapagliflozin for the treatment of HFrEF in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and health-related QoL.

The overall aim of this observational study is to describe the characteristics of patients in Italy initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns (primary objectives) as well as patient-reported outcomes including quality of life (secondary objectives).

This study is part of a multicountry study programme, including similar studies that will be conducted in other countries with similar objectives. Data from each of the individual studies may be combined in a pooled analysis.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-22
• Study Start: 2022-04-19
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-cohort	Dapagliflozin	Patients initiated on dapagliflozin according to the approved indication for heart failure with reduced ejection fraction (HFrEF) and current medical practice

Primary Outcome Measures

Name	Time	Method
Dapagliflozin treatment pattern	12 months from prescription of dapagliflozin	Treatment discontinuation events for dapagliflozin
Baseline characteristics of participants	Baseline (enrollment)	Demographic and clinical characteristics at baseline of study participants
Other medications treatment patterns	12 months from prescription of dapagliflozin	Treatment change events for other medications for heart failure and glucose-lowering medications

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)	Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)	Health-Related Quality of Life: assessment of heart failure symptoms and their impact in terms of physical limitation and quality of life, as captured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is scored on a scale from 0 to 100, with higher scores indicating higher quality of life.
Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)	Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)	Assessment of medication adherence to heart failure treatments, as captured by the five-items version of the Medication Adherence Report Scale (MARS-5). The MARS-5 is scored on a scale from 0 to 25, with higher scores indicating better treatment compliance.

Trial Locations

Locations (1)

Research Site; 🇮🇹 Napoli, Italy