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

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.

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Key information

Conditions

Sodium-GLucose coTransporter-2 Inhibitors Heart Failure With Reduced Ejection Fraction Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium-glucose cotransporter-2 Inhibitors

Drug

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

Primary outcomes

Predictors of remodeling and improvement in LV systolic and diastolic function

Time frame: 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 outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Matteo Cameli

Other

Collaborators

ASST-Rhodense; Ospedale di Circolo di Rho
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Campus Bio-Medico University
Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno
Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza
Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona
Centro Medico Sant'Agostino, Milano
Department of Advanced Biomedical Science, Federico II University Hospital, Naples
Department of Biomedical Sciences for Health, University of Milano, Milan
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 Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara
Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan
Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fondazione Toscana G. Monasterio, Pisa
ProMISE, University Hospital Paolo Giaccone, University of Palermo
Section of Cardiology, Department of Medicine, University of Verona, Verona
University Of Perugia
Università Politecnica delle Marche, Ospedali riuniti di Ancona

Registry information

Acronym: DISCOVERSGLT2i

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 25, 2022
Registry last updated: Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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