Status:
COMPLETED
Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
Lead Sponsor:
Matteo Cameli
Collaborating Sponsors:
Fondazione Toscana G. Monasterio, Pisa
University Of Perugia
Conditions:
Sodium-GLucose coTransporter-2 Inhibitors
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT05344963
Start Date
April 1 2022
End Date
June 1 2024
Last Update
February 7 2025
Active Locations (1)
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1
UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte
Siena, Italy, 53100