SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)
研究概览
简要总结
Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed.
Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Male or female from all ethnicities;
- •At least 6 months post successful, isolated MV repair. S
- •Asymptomatic
排除标准
- •Pulmonary hypertension >50 mmHg at rest;
- •Atrial fibrillation (AF) at time of study related stress echo test;
- •Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing;
- •LVEF <45%;
- •NYHA class II and more.
- •Other heart valve disease of more than mild severity;
- •Concomitant surgery during MV repair, e.g. MAZE, TVP procedure;
- •Prior heart valve surgery;
- •Congenital heart disease;
- •Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
- •Unable to provide informed consent
结局指标
主要结局
Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)
时间窗: at least 6 months after successful MV repair
Echocardiographic measured mitral valve mean gradient at peak physical exercise
Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)
时间窗: at least 6 months after successful MV repair
Echocardiographic measured sPAP at peak physical exercise
Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines)
时间窗: at least 6 months after successful MV repair
Echocardiographic measured increase in mitral valve regurgitation at peak physical exercise during physical stress echo, compared to rest echo. Grading of mitral regurgitation will be performed according to the ESC guidelines.
次要结局
- Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)(at least 6 months after successful MV repair)
- Echocardiographic parameter: Left ventricular function (LVF, quality description)(at least 6 months after successful MV repair)
- Echocardiographic parameter: Mitral valve area (MVA, cm2)(at least 6 months after successful MV repair)