Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors (DISCOVERSGLT2i)

Matteo Cameli

Status: Completed

Conditions: Sodium-GLucose coTransporter-2 Inhibitors; Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Sodium-GLucose coTransporter-2 inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT05344963

DISCOVER SGLT2i

Details and patient eligibility

About

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.

Enrollment: 503 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Providing informed consent prior to any specific study procedure
2. Female or male outpatient patients > 18 years
3. Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
4. 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

1. Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
2. Age <18 years
3. For women only - ongoing pregnancy (confirmed with positive pregnancy test)
4. For women only - breastfeeding
5. Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
6. Failure to sign informed consent.
7. Previous treatment with SGLT2i.