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

NCT05250011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 252

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Heart Failure, Reduced Ejection Fraction

Interventions

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.

Sponsors & Collaborators

  • Fullcro s.r.l.

    collaborator UNKNOWN
  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Marco Metra, MD · UOC Cardiologia, Spedali Civili di Brescia

  • Maurizio Volterrani, MD · UO Riabilitazione Cardiologica, IRCCS San Raffaele, Roma

  • Pasquale Perrone Filardi, MD · UOC Cardiologia emodinamica e UTIC, Azienda Ospedaliera Universitaria "Federico II", Napoli

  • Massimo Iacoviello, MD · Unità di Cardiologia, Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia

  • Pietro Ameri, MD · UO Clinica Malattie Apparato Cardiovascolare e UTIC, IRCCS Ospedale Policlinico San Martino, Genova

  • Andrea Ungar, MD · Geriatria UTIG, Azienda Ospedaliero Universitaria Careggi, Firenze

  • Ciro Indolfi, MD · UO Cardiologia-Emodinamica-UTIC, Azienda Ospedaliero Universitaria Mater Domini, Catanzaro

  • Massimo Volpe, MD · UOC Cardiologia, Azienda Ospedaliera Sant'Andrea, Roma

  • Andrea Mortara, MD · Dipartimento di Cardiologia, Policlinico di Monza, Monza

  • Stefano Carugo, MD · Unità di Cardiologia, IRCCS Ca' Granda - Ospedale Maggiore - Policlinico, Milano

  • Andrea Di Lenarda, MD · Cardiologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2024-04-15
Completion
2024-04-15

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250011 on ClinicalTrials.gov