Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Therapy in Patients With HFrEF.

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Ventricular Dysfunction

Ventricular Remodeling

Heart Failure

Treatments

Drug: SGLT2 inhibitor

Study type

Observational

Funder types

Other

Identifiers

NCT05934071

5428

Details and patient eligibility

About

The goal of this observational study is to investigate the effects of combination therapy with ARNI and inhibitors of SGLT2 in patients affected by HFrEF.

The main questions it aims to answer are:

What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied by speckle tracking echocardiography (GLS%) and by variation of volumetric indices and contractile function (LVEDV, LVEDD, FE%)?
What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (NT-pro-BNP)?
What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of major cardiovascular events (MACVE)?
What are the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling? Participants will undergo, at the time of enrollment and after approximately 3 and 12 months from the introduction of SGLT-2 inhibitor therapy, at clinical, echocardiographic and biohumoral investigations.

Full description

According to the 2021 ESC guidelines for heart failure, iSGLT2 has become the cornerstone of the treatment of heart failure with reduced ejection (HFrEF) fraction, with a class of recommendation IA (1).

However, the mechanisms of action of iSGLT2 remain still little known. In particular, if the combined therapy with ARNI and iSGLT2 may have an effect in terms of left ventricular remodeling evaluated by speckle tracking echocardiography (GLS%) in patients with HFrEF at a medium-long term (3-12 months) is still to be defined (primary objective).

Furthermore, our study will aim to evaluate the clinical and echocardiographic impact of the combined therapy with ARNI + iSGLT2 in terms of left ventricular remodeling evaluated through volumetric and contractile function indices (LVEDV, LVEDD, FE%) and in terms of variation of laboratory data suggestive of decompensated heart failure (NT-pro-BNP) in patients with HFrEF at a medium-long term follow-up (3-12 months) (secondary outcomes).

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HFrEF on ARNI
Ability to express written informed consent to participate in the study

Exclusion criteria

Contraindication to glyphozine therapy (i.e., severe renal insufficiency with filtration estimated glomerular <30ml/min/m2 or history of recurrent urinary tract infections);
Comorbidities with expected survival of less than 1 year;
Limited or legal inability to give written informed consent