Status:
COMPLETED
SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Heart Failure
ICD
Eligibility:
All Genders
18-75 years
Brief Summary
Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent su...
Eligibility Criteria
Inclusion
- stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction \<35%; patients receiving optimal medical therapy without controindications to receive SGLT2i; diagnosis of T2DM.
Exclusion
- NYHA Class I, and IV; co-morbidities which may limit life to \<6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 26 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03366181
Start Date
November 1 2017
End Date
November 26 2017
Last Update
January 20 2025
Active Locations (1)
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1
Raffaele Marfella
Naples, Italy, Italy, 80128