Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SGLT2 inhibitor group
Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
干预措施: Dapagliflozin Propanediol Hydrate 12.3 mg (Drug)
结局指标
主要结局
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
时间窗: Baseline and month 12
RVESV index at 12 months - RVESV index at baseline
次要结局
- 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)
研究者
Sung-Ji Park
Professor
Samsung Medical Center