Clinical trial NCT05250011: Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice
Official title: Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Reduced Ejection Fraction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Fullcro s.r.l.
First posted: 2022-02-22
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Baseline characteristics of participants
timeFrame: Baseline (enrollment)
measure: Dapagliflozin treatment pattern
timeFrame: 12 months from prescription of dapagliflozin
measure: Other medications treatment patterns
timeFrame: 12 months from prescription of dapagliflozin
Secondary outcomes:
measure: Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
measure: Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)
timeFrame: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Research Site
state: BS
city: Catanzaro
country: Italy
facility: Research Site
state: CZ
city: Foggia
country: Italy
facility: Research Site
state: FG
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Monza
country: Italy
facility: Research Site
state: MB
city: Milano
country: Italy
facility: Research Site
state: MI
city: Roma
country: Italy
facility: Research Site
state: RM
city: Roma
country: Italy
facility: Research Site
state: RM
city: Trieste
country: Italy
facility: Research Site
state: TS
city: Napoli
country: Italy
facility: Research Site
Study officials:
affiliation: UOC Cardiologia, Spedali Civili di Brescia
name: Marco Metra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UO Riabilitazione Cardiologica, IRCCS San Raffaele, Roma
name: Maurizio Volterrani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOC Cardiologia emodinamica e UTIC, Azienda Ospedaliera Universitaria "Federico II", Napoli
name: Pasquale Perrone Filardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unità di Cardiologia, Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia
name: Massimo Iacoviello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UO Clinica Malattie Apparato Cardiovascolare e UTIC, IRCCS Ospedale Policlinico San Martino, Genova
name: Pietro Ameri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geriatria UTIG, Azienda Ospedaliero Universitaria Careggi, Firenze
name: Andrea Ungar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UO Cardiologia-Emodinamica-UTIC, Azienda Ospedaliero Universitaria Mater Domini, Catanzaro
name: Ciro Indolfi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOC Cardiologia, Azienda Ospedaliera Sant'Andrea, Roma
name: Massimo Volpe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Cardiologia, Policlinico di Monza, Monza
name: Andrea Mortara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unità di Cardiologia, IRCCS Ca' Granda - Ospedale Maggiore - Policlinico, Milano
name: Stefano Carugo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste
name: Andrea Di Lenarda, MD
role: PRINCIPAL_INVESTIGATOR
References: