The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.
After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to SGLT2i add-on group or conventional treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Samsung Medical Center
Seoul, South Korea
RECRUITINGDifference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
RVESV index at 12 months - RVESV index at baseline
Time frame: Baseline and month 12
Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
RVEDV index at 12 months - RVEDV index at baseline
Time frame: Baseline and month 12
Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
RVEF at 12 months - RVEF at baseline
Time frame: Baseline and month 12
Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)
TR VCW at 12 months - TR VCW at baseline
Time frame: Baseline and month 12
Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up
Tricuspid annulus diameter at 12 months - Tricuspid annulus diameter at baseline
Time frame: Baseline and month 12
Difference of TR volume by CMR from baseline to 12 months follow-up
TR volume at 12 months - TR volume at baseline
Time frame: Baseline and month 12
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