Tricuspid Regurgitation
Conditions
Keywords
tricuspid regurgitation, SGLT2 inhibitor
Brief 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.
Detailed description
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.
Interventions
DRUGDapagliflozin Propanediol Hydrate 12.3 mg
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi) | Baseline and month 12 | RVESV index at 12 months - RVESV index at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF) | Baseline and month 12 | RVEF at 12 months - RVEF at baseline |
| Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi) | Baseline and month 12 | RVEDV index at 12 months - RVEDV index at baseline |
| Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW) | Baseline and month 12 | TR VCW at 12 months - TR VCW at baseline |
| Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up | Baseline and month 12 | Tricuspid annulus diameter at 12 months - Tricuspid annulus diameter at baseline |
| Difference of TR volume by CMR from baseline to 12 months follow-up | Baseline and month 12 | TR volume at 12 months - TR volume at baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference of NT-proBNP from baseline to 12 months follow-up | Baseline and month 12 | NT-proBNP at 12 months - NT-proBNP at baseline |
| Occurrence of renal dysfunction (creatinine > 2mg/dL) | 12 months after enrollment | Newly developed renal dysfunction during follow-up period |
| Occurrence of tricuspid valve surgery during 12 months | 12 months after enrollment | TV surgery |
| Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months | 12 months after enrollment | development of cardiovascular death or admission for heart failure |
Countries
South Korea
Contacts
Primary ContactEun Kyoung Kim, MD. PhD
Backup ContactJi Hoon Kim, MD, PhD
Outcome results
None listed