DISCOVERSGLT2i: Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors

Sponsor

Matteo Cameli (Other)

Overall Status

Recruiting

CT.gov ID

NCT05344963

Collaborator

Fondazione Toscana G. Monasterio, Pisa (Other), Cardiology and Cardiovascular Pathophysiology - Heart Failure Unit; "Santa Maria della Misericordia" Hospital, University of Perugia (Other), Section of Cardiology, Department of Medicine, University of Verona, Verona (Other), Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome (Other), Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona (Other), Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza (Other), University Cardiology Unit, Cardiothoracic Department, Polyclinic University Hospital, Bari (Other), ProMISE, University Hospital Paolo Giaccone, University of Palermo (Other), Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna (Other), Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia (Other), Department of Biomedical Sciences for Health, University of Milano, Milan (Other), Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan (Other), Department of Advanced Biomedical Science, Federico II University Hospital, Naples (Other), Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara (Other), Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN (Other), ASST-Rhodense; Ospedale di Circolo di Rho (Other), Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno (Other), Centro Medico Sant'Agostino, Milano (Other), Università Politecnica delle Marche, Ospedali riuniti di Ancona (Other), Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma (Other)

300

Enrollment

Location

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sodium-GLucose coTransporter-2 Inhibitors Heart Failure With Reduced Ejection Fraction	Drug: Sodium-GLucose coTransporter-2 inhibitors

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Providing informed consent prior to any specific study procedure
Female or male outpatient patients > 18 years
Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
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:

Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
Age <18 years
For women only - ongoing pregnancy (confirmed with positive pregnancy test)
For women only - breastfeeding
Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
Failure to sign informed consent.
Previous treatment with SGLT2i.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte	Siena		Italy	53100

Sponsors and Collaborators

Matteo Cameli
Fondazione Toscana G. Monasterio, Pisa
Cardiology and Cardiovascular Pathophysiology - Heart Failure Unit; "Santa Maria della Misericordia" Hospital, 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
University Cardiology Unit, Cardiothoracic Department, Polyclinic University Hospital, 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