Right Ventricular Haemodynamic Evaluation and Response to Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography
研究概览
简要总结
Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients
详细描述
Mono-center-study tu evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multimodal parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds
- •ability to sign informed consent
- •male and female between 18 to 85 years
- •haemodynamic criteria:
- •Pulmonary vascular resistance (PVR) > 240 dyn x sec x cm-5
- •Mean Pulmonary artery pressure (mPAP) ≥ 25 mmHg for PAH patients
- •normal haemodynamic in controls
- •therapy-naive or at least since two months stabil therapy with approved drugs for PAH (Sildenafil, Tadalafil, Macitentan, Ambrisentan, Bosentan, Iloprost, Treprostinil, Riociguat).
排除标准
- •therapy with positive inotropic drugs (dobutamin etc.)
- •missing informed consent
- •pregnancy or lactation
结局指标
主要结局
Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography
时间窗: 12 weeks
right ventricular contractility can be obtained via different methods, our aim is to compare the different methods. Ees is the endsystolic elastance which describes the contractility of the right ventricle
次要结局
- dp/dt max and min from Pressure-Wire vs. Conductance Katheter(12 weeks)
- Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)(12 weeks)
- Comparibility of pressures measured via pressure wire and conductance catheter(12 weeks)
研究者
Jan Grimminger
Principle Investigator
University of Giessen