None listed
Conditions
Interventions
Drug : Intervention group: Treatment of existing drugs + SGLT2 inhibitors (Dapagliflozin 10mg or Empagliflozin 10mg) Take PO once a day for one year
Control group: Traditional drug treatment
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who understands the research protocol and has completed a written consent form 2) adult men and women over the age of 20 3) a patient with severe tricuspid valve regurgitation (1) Even in conventional drug treatment, if Vena contacta > 0.7 cm or effective reflux area =40 mm2 for more than 1 month (2) a patient with a left ventricular ejection fraction of 40% or more* (3) Persons with dyspnea of function classification II or higher by the New York Heart Association (NYHA)
Exclusion criteria
Exclusion criteria: 1) Severe mitral valve or aortic valve disease 2) Left ventricular ejection fraction less than 40%* 3) In case of severe pulmonary hypertension (TR Vmax > 4m/s) 4) Acute heart failure or dyspnea above NYHA functional class IV 5) Systolic blood pressure below 90 mmHg 6) Severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary arterial embolism) 7) Estimated glomerular filtration rate < 30ml/min/1.73m2 or on dialysis 8) Type 1 diabetes 9) Pregnancy or lactation 10) If MRI imaging is not possible (fear of loss in case of undergoing Pacemaker or defibrillator or insertion of a metal prosthesis or Claustrophobia) 11) In case of liver disease, AST or ALT values are more than twice the upper limit of normal, history of hepatic coma, history of esophageal varices, and history of Portocaval shunt/anastomosis 12) A person whose life expectancy is less than one year 13) If SGLT-2 inhibitors are already being administered 14) In case of hypersensitivity to SGLT2 inhibitors 15) Other persons deemed unsuitable by the tester to participate in this clinical trial * Evidence for setting patients with a left ventricular ejection fraction of 40% or higher as the selection criteria and setting patients with a left ventricular ejection fraction of less than 40% as the exclusion criteria: If there is a decrease in left ventricular contractile function, functional tricuspid valve reflux may be accompanied by a decrease in left ventricular function, and in this case, in order to reduce tricuspid valve reflux, it is a category that requires treatment for the cause of left ventricular dysfunction, so patients who fall under this category are excluded from the study. To this end, patients with a left ventricular ejection fraction of less than 40% are excluded in accordance with the definition of left ventricular contractile dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of RVESVi by CMR from baseline to 12 months follow-up by two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of RVEDVi by CMR from baseline to 12 months follow-up (?RVEDVi) by two groups ;Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (?RVEF) by two groups;Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (?VCW) by two groups;Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up by two groups;Difference of TR volume by CMR from baseline to 12 months follow-up by two groups;Occurrence of cardiovascular death or hospitalization for right heart failure during 12 months by two groups;Occurrence of tricuspid valve surgery during 12 months by two groups ;Difference of NT-proBNP from baseline to 12 months follow-upby two groups ;Occurrence of renal dysfunction (creatinine > 2mg/dL) two groups | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Ji Park
Samsung Medical Center
Outcome results
None listed