Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Death or heart failure hospitalization
研究概览
简要总结
Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.
详细描述
Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery.
Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement.
RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography.
Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Severe functional tricuspid regurgitation.
- •Planned surgical or interventional tricuspid valve repair or replacement.
- •Able to cycle on a semisupine tilting exercise table.
- •Informed consent.
排除标准
- •Coronary artery disease with significant ischemia.
- •Unstable Angina.
- •Myocardial infarction <4 month prior to inclusion.
- •Concomitant valvular heart disease (aortic, mitral or pulmonary valve) > mild-moderate.
- •Constrictive pericarditis.
- •Malignant disease with a life expectancy < 12 months.
- •Pregnancy.
- •Insufficient image quality on echocardiography.
结局指标
主要结局
Death or heart failure hospitalization
时间窗: 6-12 month
Death or heart failure hospitalization according to right ventricular contractile reserve.
次要结局
- Intrinsic RV contractility(Baseline)
- Cardiovascular Death(6-12 month)
- Heart Failure Hospitalization(6-12 month)
- Death(6-12 month)
研究者
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital