NCT05344963

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 503 (actual)
• Sponsor: Matteo Cameli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2022-04-25
• Last updated: 2025-02-07

Locations

1 site across 1 country: Italy