TEER In dynaMic sEvere Functional Mitral Regurgitation：A Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- The rate of the recurrent composite of cardiovascular (CV) death and heart failure hospitalization (HFH) over the entire follow-up period (analyzed when the last subject completes 12 m of follow up).
研究概览
简要总结
Functional mitral regurgitation is a highly dynamic disease. Some patients exhibit only moderate(2+) functional mitral regurgitation at rest, which deteriorates to moderate-to-severe or severe FMR(3+ or 4+) during stress-termed dynamic severe functional mitral regurgitation. Observational studies link this condition to worse outcomes, with mitral valve intervention offering potential benefits; however, high-quality evidence remains lacking.
The Transcatheter Edge-to-Edge Repair In DynaMic sEvere Functional Mitral Regurgitation trial aims to assess the safety and effectiveness of transcatheter edge-to-edge repair plus guideline-directed medical therapy versus guideline-directed medical therapy alone in symptomatic chronic heart failure patients with dynamic severe functional mitral regurgitation, defined as moderate regurgitation at rest deteriorating to severe during handgrip stress echocardiography.
This prospective, multi-center, randomized trial enrolls patients with dynamic severe functional mitral regurgitation confirmed by a core laboratory using handgrip stress echocardiography. Patients are randomized 1:1 to transcatheter edge-to-edge repair plus medical therapy or medical therapy alone. The primary endpoint is the composite of Cardiovascular death or heart failure hospitalization over the entire period.
This trial will provide critical evidence on transcatheter edge-to-edge repair in patients with dynamic severe functional mitral regurgitation, informing future treatment recommendations.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically significant functional mitral regurgitation (MR (2+) at rest that deteriorates to moderate-to-severe (3+) or severe (4+) FMR during standardized handgrip stress echocardiography, with ΔEROA ≥0.1cm²) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- •Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
- •Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
- •Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- •Left ventricular ejection fraction (LVEF) of ≥ 20% Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization
- •Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness
排除标准
- •Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
- •Status 1 heart transplant or prior orthotropic heart transplantation.
- •Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
- •Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
- •Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization.
- •Need for any cardiovascular surgery.
- •Mitral valve surgery is considered the preferred therapeutic option for the subject
- •Renal replacement therapy
- •6-Minute Walk Test (6MWT) distance > 475 meters
- •Mitral Valve Area (MVA) by planimetry < 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
研究组 & 干预措施
Control group
GDMT
干预措施: GDMT (Drug)
TEER+GDMT
TEER +GDMT
干预措施: TEER (Device)
TEER+GDMT
TEER +GDMT
干预措施: GDMT (Drug)
结局指标
主要结局
The rate of the recurrent composite of cardiovascular (CV) death and heart failure hospitalization (HFH) over the entire follow-up period (analyzed when the last subject completes 12 m of follow up).
时间窗: 2 years
Cardiovascular death or heart failure hospitalization (HFH) occurring within 2 years after enrollment
Rehospitalization rate
时间窗: 24 months
Rehospitalization rate within 24 months
次要结局
- Mitral Regurgitation (MR severity reduction to MR ≤2+ under stress) at 12 months(5 years)
- Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months.(5 years)
- Changes in 6-minute walk test (6MWT) distance at 12 months.(5 years)
- Changes in NYHA functional class at 12 months.(5 years)
- KCCQ(24 months)
- NYHA class(24 months)
- 6-min walk test(24 months)
- MACE(24 months)
研究者
Xiao-dong Zhuang
The first affiliated hospital of Sun Yat-Sen University
Sun Yat-sen University