Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2022-04-13
2025-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SGLT2 inhibitor group
Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
Dapagliflozin Propanediol Hydrate 12.3 mg
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Conventional treatment group
Participants will continue the existing medications for severe TR.
No interventions assigned to this group
Interventions
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Dapagliflozin Propanediol Hydrate 12.3 mg
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
90 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Sung-Ji Park
Professor
Principal Investigators
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Sung Ji Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heart Vascular Stroke Institute, Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Reduction TR
Identifier Type: -
Identifier Source: org_study_id
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