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

Heart Failure, Reduced Ejection Fraction Clinical Trial

— EVOLUTION-HF  

Official title:

Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250011
• Other study ID #: D1699R00030
• Status: Completed
• Start date: April 19, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Reduced Ejection Fraction
• Heart Failure, Systolic

Intervention

Drug:
• Dapagliflozin
Dapagliflozin, prescribed as per approved indication and current medical practice. Participants will not receive any experimental disease management intervention or experimental treatment as a consequence of their participation in the study.

Locations

Country	Name	City	State
Italy	Research Site	Brescia	BS
Italy	Research Site	Catanzaro	CZ
Italy	Research Site	Firenze	FI
Italy	Research Site	Foggia	FG
Italy	Research Site	Genova	GE
Italy	Research Site	Milano	MI
Italy	Research Site	Monza	MB
Italy	Research Site	Napoli
Italy	Research Site	Roma	RM
Italy	Research Site	Roma	RM
Italy	Research Site	Trieste	TS

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Fullcro s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristics of participants	Demographic and clinical characteristics at baseline of study participants	Baseline (enrollment)
Primary	Dapagliflozin treatment pattern	Treatment discontinuation events for dapagliflozin	12 months from prescription of dapagliflozin
Primary	Other medications treatment patterns	Treatment change events for other medications for heart failure and glucose-lowering medications	12 months from prescription of dapagliflozin
Secondary	Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
Secondary	Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)	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.	Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)