SGLT2 Inhibitor for Severe Tricuspid Regurgitation
- Conditions
- Tricuspid Regurgitation
- Interventions
- Registration Number
- NCT05686616
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SGLT2 inhibitor group Dapagliflozin Propanediol Hydrate 12.3 mg Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 TR volume by CMR from baseline to 12 months follow-up Baseline and month 12 TR volume at 12 months - TR volume 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 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 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of