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

NCT ID: NCT05250011

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 252 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2024-04-15

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.

Conditions

Heart Failure, Reduced Ejection Fraction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Single-cohort

Patients initiated on dapagliflozin according to the approved indication for heart failure with reduced ejection fraction (HFrEF) and current medical practice

Dapagliflozin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Forxiga

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fullcro s.r.l.

UNKNOWN

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Metra, MD

Role: PRINCIPAL_INVESTIGATOR

UOC Cardiologia, Spedali Civili di Brescia

Maurizio Volterrani, MD

Role: PRINCIPAL_INVESTIGATOR

UO Riabilitazione Cardiologica, IRCCS San Raffaele, Roma

Pasquale Perrone Filardi, MD

Role: PRINCIPAL_INVESTIGATOR

UOC Cardiologia emodinamica e UTIC, Azienda Ospedaliera Universitaria "Federico II", Napoli

Massimo Iacoviello, MD

Role: PRINCIPAL_INVESTIGATOR

Unità di Cardiologia, Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia

Pietro Ameri, MD

Role: PRINCIPAL_INVESTIGATOR

UO Clinica Malattie Apparato Cardiovascolare e UTIC, IRCCS Ospedale Policlinico San Martino, Genova

Andrea Ungar, MD

Role: PRINCIPAL_INVESTIGATOR

Geriatria UTIG, Azienda Ospedaliero Universitaria Careggi, Firenze

Ciro Indolfi, MD

Role: PRINCIPAL_INVESTIGATOR

UO Cardiologia-Emodinamica-UTIC, Azienda Ospedaliero Universitaria Mater Domini, Catanzaro

Massimo Volpe, MD

Role: PRINCIPAL_INVESTIGATOR

UOC Cardiologia, Azienda Ospedaliera Sant'Andrea, Roma

Andrea Mortara, MD

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Cardiologia, Policlinico di Monza, Monza

Stefano Carugo, MD

Role: PRINCIPAL_INVESTIGATOR

Unità di Cardiologia, IRCCS Ca' Granda - Ospedale Maggiore - Policlinico, Milano

Andrea Di Lenarda, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

Locations

Research Site

Brescia, BS, Italy

Research Site

Catanzaro, CZ, Italy

Research Site

Foggia, FG, Italy

Research Site

Florence, FI, Italy

Research Site

Genova, GE, Italy

Research Site

Monza, MB, Italy

Research Site

Milan, MI, Italy

Research Site

Roma, RM, Italy

Research Site

Roma, RM, Italy

Research Site

Trieste, TS, Italy

Research Site

Napoli, , Italy

Countries

Italy

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1699R00030&attachmentIdentifier=87c18942-4519-441b-8831-b573afd2e3e1&fileName=D1699R00030_Redacted_CSR_Synopsis.pdf&versionIdentifier=

redacted CSR Synopsis

Other Identifiers

D1699R00030

Identifier Type: -

Identifier Source: org_study_id