Heart Failure With Reduced Ejection Fraction, Sodium-GLucose coTransporter-2 Inhibitors
Conditions
Keywords
Echocardigraphy, Speckle tracking, Strain, SGLT2i
Brief summary
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.
Interventions
Evaluation of the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with the SGLT2i drugs Dapagliflozin and Empagliflozin
Sponsors
Fondazione Toscana G. Monasterio, Pisa
University Of Perugia
Section of Cardiology, Department of Medicine, University of Verona, Verona
Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome
Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona
Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
ProMISE, University Hospital Paolo Giaccone, University of Palermo
Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna
Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia
Department of Biomedical Sciences for Health, University of Milano, Milan
Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan
Department of Advanced Biomedical Science, Federico II University Hospital, Naples
Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara
Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN
ASST-Rhodense; Ospedale di Circolo di Rho
Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno
Centro Medico Sant'Agostino, Milano
Università Politecnica delle Marche, Ospedali riuniti di Ancona
Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma
Matteo Cameli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of remodeling and improvement in LV systolic and diastolic function | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 18 months | 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. |
Countries
Italy
Outcome results
None listed