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

Matteo Cameli503 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

503

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Predictors of remodeling and improvement in LV systolic and diastolic function

A univariate and multivariate logistic regression analysis will be performed to search for predictors of remodeling and improvement in LV systolic and diastolic function at 6 months, with particular attention to advanced echocardiography parameters.

Time frame: 18 months

Secondary Outcomes

Combined outcome 12 months from the third evaluation (18 months from the start of therapy) including death from cardiovascular causes, appropriate defibrillator discharge, hospitalizations or episodes of atrial fibrillation.

Uni and multivariate Cox analyzes will be performed for predictors of cardiovascular events and the quality of the model will then be estimated by time-dependent ROC analysis.