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

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.

Conditions

• Sodium-GLucose coTransporter-2 Inhibitors
• Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

Sodium-GLucose coTransporter-2 inhibitors

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 & Collaborators

• Fondazione Toscana G. Monasterio, Pisa

  collaborator UNKNOWN

• University Of Perugia

  collaborator OTHER

• Section of Cardiology, Department of Medicine, University of Verona, Verona

  collaborator UNKNOWN

• Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome

  collaborator UNKNOWN

• Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona

  collaborator UNKNOWN

• Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  collaborator OTHER

• ProMISE, University Hospital Paolo Giaccone, University of Palermo

  collaborator UNKNOWN

• Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna

  collaborator UNKNOWN

• Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia

  collaborator UNKNOWN

• Department of Biomedical Sciences for Health, University of Milano, Milan

  collaborator UNKNOWN

• Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan

  collaborator UNKNOWN

• Department of Advanced Biomedical Science, Federico II University Hospital, Naples

  collaborator UNKNOWN

• Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara

  collaborator UNKNOWN

• Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN

  collaborator UNKNOWN

• ASST-Rhodense; Ospedale di Circolo di Rho

  collaborator UNKNOWN

• Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno

  collaborator UNKNOWN

• Centro Medico Sant'Agostino, Milano

  collaborator UNKNOWN

• Università Politecnica delle Marche, Ospedali riuniti di Ancona

  collaborator UNKNOWN

• Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma

  collaborator UNKNOWN

• Matteo Cameli

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-01

Primary Completion

2024-05-01

Completion

2024-06-01

Countries

• Italy

Study Locations