An observational study in Heart Failure, Ventricular Remodeling and Ventricular Dysfunction, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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:
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).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 160 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Patients affected by HFrEF on ARNI, eligible for glyphozine
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients affected by HFrEF in optimized medical therapy including ARNI, eligible for glyphozine
Drug: SGLT2 inhibitor
optimization of the medical therapy for heart failure with reduced ejection fraction with SGLT2 inhibitor, according to clinical guidelines
Also known as: Dapaglifozin, Empaglifozin
ventricular remodeling studied by speckle tracking echocardiography
Evaluation of the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied through speckle tracking echocardiography and evaluated in terms of global longitudinal strain values (GLS%)
Time frame: 3-12 months
variation of volumetric indices and contractile function
Evaluation of the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied through echocardiography and evaluated as LV volumes (end diastolic volumes-ml/m2 and and systolic volumes ml/m2) and LV function (left ventricular ejection fraction-%) indices
Time frame: 3-12 months
variation of laboratory data indicative of heart failure (NT-pro-BNP)
Evaluation of the medium-long term impact of the ARNI + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (N-terminal pro B type natriuretic peptide-pg/mL)
Time frame: 3-12 months
major cardiovascular events (MACVE)
Evaluation of the medium-long term impact of the ARNI + glyphozine combination therapy in terms of major adverse cardiovascular events (composite endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke)
Time frame: 3-12 months
echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling
Identification of the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling in terms of variation of LV volumes (end diastolic volumes-ml/m2 and and systolic volumes ml/m2) and LV function (left ventricular ejection fraction-%) indices
Time frame: 3-12 months
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