Overview
It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i Dapagliflozin and Empagliflozin.
Participation in the study will last for approximately 18 months, and a total of 300 patients will be enrolled at the various Research Centers.
The enrolled patients will undergo a first evaluation in which the anamnestic, clinical and conventional and advanced echocardiographic data will be recorded. At this point, the patient will start SGLT2i.
After starting SGLT2i, a second evaluation will be carried out with a cardiological visit at 6 months, in which the same data listed above will then be recorded.
At the end of the evaluation, the clinical follow-up will be continued for the duration of 1 year, in number and frequency according to clinical indication.
Eligibility
Inclusion Criteria:
- Providing informed consent prior to any specific study procedure
- Female or male outpatient patients > 18 years
- Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
- Already on therapy with an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization
Exclusion Criteria:
- Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- Age <18 years
- For women only - ongoing pregnancy (confirmed with positive pregnancy test)
- For women only - breastfeeding
- Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
- Failure to sign informed consent.
- Previous treatment with SGLT2i.