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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2 inhibitor group | Active Comparator | Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks. |
|
| Conventional treatment group | No Intervention | Participants will continue the existing medications for severe TR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin Propanediol Hydrate 12.3 mg | Drug | Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi) | RVESV index at 12 months - RVESV index at baseline | Baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi) | RVEDV index at 12 months - RVEDV index at baseline | Baseline and month 12 |
| Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months | development of cardiovascular death or admission for heart failure | 12 months after enrollment |
| Occurrence of tricuspid valve surgery during 12 months |
Inclusion Criteria:
Participant over 20 years of age who understands the research protocol and has written informed consent
Participant with severe tricuspid valve regurgitation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Kyoung Kim, MD. PhD | Contact | 82-2-3410-3419 | ekbobi.kim@samsung.com | |
| Ji Hoon Kim, MD, PhD | Contact | 82-2-3410-3419 | jh9933.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Sung Ji Park, MD, PhD | Heart Vascular Stroke Institute, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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RVEF at 12 months - RVEF at baseline
| 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 | 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 | 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 | Baseline and month 12 |
TV surgery
| 12 months after enrollment |
| Difference of NT-proBNP from baseline to 12 months follow-up | NT-proBNP at 12 months - NT-proBNP at baseline | Baseline and month 12 |
| Occurrence of renal dysfunction (creatinine > 2mg/dL) | Newly developed renal dysfunction during follow-up period | 12 months after enrollment |