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

NCT05250011 | Completed

• 1 other identifier: D1699R00030
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 11

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.

Conditions

Heart Failure, Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (3)

• Baseline characteristics of participants

  Demographic and clinical characteristics at baseline of study participants

  Baseline (enrollment)

• Dapagliflozin treatment pattern

  Treatment discontinuation events for dapagliflozin

  12 months from prescription of dapagliflozin

• Other medications treatment patterns

  Treatment change events for other medications for heart failure and glucose-lowering medications

  12 months from prescription of dapagliflozin

Secondary Outcomes (2)

• Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)

• Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)

  Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)

Study Arms (1)

Single-cohort

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

Drug: Dapagliflozin

Interventions

Dapagliflozin 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.

Also known as: Forxiga

Single-cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients prescribed with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) according to the approved indication will be eligible for enrollment from both outpatient and inpatient settings. The decision to treat a patient with dapagliflozin must be made prior to the decision to enroll the patient. In order to help ensuring this, participants can be enrolled only if they started treatment with dapagliflozin at least 14 days before the enrollment visit, regardless of the treatment being discontinued or suspended in the time between first dapagliflozin prescription and enrollment visit. It is expected that 250 participants will be consecutively enrolled in about 11 centres (approximately 23 participants per each study site).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Fullcro s.r.l.: collaborator

Study Sites (11)

Research Site

Brescia, BS, 25123, Italy

Location

Research Site

Catanzaro, CZ, 88100, Italy

Location

Research Site

Foggia, FG, 71122, Italy

Location

Research Site

Florence, FI, 50100, Italy

Location

Research Site

Genova, GE, 16132, Italy

Location

Research Site

Monza, MB, 20900, Italy

Location

Research Site

Milan, MI, 20122, Italy

Location

Research Site

Roma, RM, 00163, Italy

Location

Research Site

Roma, RM, 00189, Italy

Location

Research Site

Trieste, TS, 34125, Italy

Location

Research Site

Napoli, 80131, Italy

Location

Related Links

• redacted CSR Synopsis

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Marco Metra, MD

  UOC Cardiologia, Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

• Maurizio Volterrani, MD

  UO Riabilitazione Cardiologica, IRCCS San Raffaele, Roma

  PRINCIPAL INVESTIGATOR

• Pasquale Perrone Filardi, MD

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

  PRINCIPAL INVESTIGATOR

• Massimo Iacoviello, MD

  Unità di Cardiologia, Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia

  PRINCIPAL INVESTIGATOR

• Pietro Ameri, MD

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

  PRINCIPAL INVESTIGATOR

• Andrea Ungar, MD

  Geriatria UTIG, Azienda Ospedaliero Universitaria Careggi, Firenze

  PRINCIPAL INVESTIGATOR

• Ciro Indolfi, MD

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

  PRINCIPAL INVESTIGATOR

• Massimo Volpe, MD

  UOC Cardiologia, Azienda Ospedaliera Sant'Andrea, Roma

  PRINCIPAL INVESTIGATOR

• Andrea Mortara, MD

  Dipartimento di Cardiologia, Policlinico di Monza, Monza

  PRINCIPAL INVESTIGATOR

• Stefano Carugo, MD

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

  PRINCIPAL INVESTIGATOR

• Andrea Di Lenarda, MD

  Cardiologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 22, 2022
• Study Start: April 19, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

IT (11)