Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Dapagliflozin Propanediol Hydrate 12.3 mg
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Samsung Medical Center
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Sung-Ji Park
Professor
Samsung Medical Center
Eligibility Criteria
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
Arms & Interventions
SGLT2 inhibitor group
Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
Intervention: Dapagliflozin Propanediol Hydrate 12.3 mg
Outcomes
Primary Outcomes
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
Time Frame: Baseline and month 12
RVESV index at 12 months - RVESV index at baseline
Secondary Outcomes
- Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)(Baseline and month 12)
- Difference of TR volume by CMR from baseline to 12 months follow-up(Baseline and month 12)
- Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)(Baseline and month 12)
- Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)(Baseline and month 12)
- Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up(Baseline and month 12)