SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Drug: Dapagliflozin Propanediol Hydrate 12.3 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant over 20 years of age who understands the research protocol and has written informed consent 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: Patient with severe mitral valve or aortic valve disease Left ventricular ejection fraction less than 40%* Patient with severe pulmonary hypertension (TR Vmax > 4m/s) Patient with acute heart failure or dyspnea of NYHA functional class IV or higher Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism) Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis Patient with Type 1 diabetes If a woman of childbearing potential has not used double contraception Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging 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) Life expectancy is less than one year Patient who already take SGLT-2 inhibitor A history of hypersensitivity or allergy to SGLT2 inhibitor

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SGLT2 inhibitor group<br>Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks. | Drug: Dapagliflozin Propanediol Hydrate 12.3 mg<br>* Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.<br>* Other names: Forxiga Tablet 10mg;|
| No Intervention: Conventional treatment group<br>Participants will continue the existing medications for severe TR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tricuspid regurgitation, SGLT2 inhibitor