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.

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.

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

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).

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca sponsored studies via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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

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