Overview

SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Status:
Recruiting
Trial end date:
2025-03-03
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Dapagliflozin
Criteria
Inclusion Criteria:

1. Participant over 20 years of age who understands the research protocol and has written
informed consent

2. Participant with severe tricuspid valve regurgitation

- Vena contracta width > 0.7cm or effective regurgitant orifice (ERO)≥40mm2 for
more than 1 month despite medical treatment

- Participant with left ventricular ejection fraction ≥ 40%

- Participant with NYHA class II or more

Exclusion Criteria:

1. Patient with severe mitral valve or aortic valve disease

2. Left ventricular ejection fraction less than 40%*

3. Patient with severe pulmonary hypertension (TR Vmax > 4m/s)

4. Patient with acute heart failure or dyspnea of NYHA functional class IV or higher

5. Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening

6. Patient with severe lung disease (asthma, obstructive pulmonary disease, acute
pulmonary embolism)

7. Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis

8. Patient with Type 1 diabetes

9. If a woman of childbearing potential has not used double contraception

10. Patients with claustrophobia or with metallic implants unsuitable for magnetic
resonance imaging

11. Blood AST or ALT value is more than twice the upper limit of normal or symptoms and
signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of
symptomatic ascites)

12. Life expectancy is less than one year

13. Patient who already take SGLT-2 inhibitor

14. A history of hypersensitivity or allergy to SGLT2 inhibitor