Clinical trial NCT05934071: Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Therapy in Patients With HFrEF.
Official title: Evaluation of the Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Combined Therapy in Patients With HFrEF: an Echocardiographic Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ventricular Remodeling
Ventricular Dysfunction
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by HFrEF on ARNI, eligible for glyphozine

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: ventricular remodeling studied by speckle tracking echocardiography
timeFrame: 3-12 months
Secondary outcomes:
measure: variation of volumetric indices and contractile function
timeFrame: 3-12 months
measure: variation of laboratory data indicative of heart failure (NT-pro-BNP)
timeFrame: 3-12 months
measure: major cardiovascular events (MACVE)
timeFrame: 3-12 months
measure: echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCSS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
name: NADIA ASPROMONTE, Prof.
role: PRINCIPAL_INVESTIGATOR
References: