Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- functional exercise capacity
研究概览
简要总结
A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to
-
- evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
-
- evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
详细描述
Valvular pulmonary stenosis (PS), defined as an obstruction of blood flow at the level of the pulmonary valve, is a form of congenital heart disease, described in 0.6-0.8 out of 1000 live births.
The main physiologic effect of valvular pulmonary stenosis (PS) is an increase in Right ventricular pressure proportional to the severity of obstruction. This elevation of RV pressure is accompanied by an increase in muscle mass where hyperplasia of the muscle cells with a concomitant increase in the number of capillaries occurs. In contrast, the adult myocardium responds with hypertrophy of the existing fibers, with no change in the capillary network. Percutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. the aim is to
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- evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
-
- evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-Adult population with an age more than or equal to 16 years of age at time of procedure 2-Severe valvular Pulmonary stenosis defined as a PG max more than or equal to 64 mmHg measured by 2d echo before Procedure
排除标准
- •Patients with isolated supra-valvular and sub valvular pulmonary stenosis
- •Patients with peripheral pulmonary stenosis.
- •Patients with pulmonary stenosis if part of another congenital heart disease .
- •Patients with organically diseased Tricuspid valve
- •Patients with any significant shunt lesion which result in dilation in RV such as atrial septal defect.
- •Patients with right ventricular dysfunction due to arrhythmogenic right ventricular dysplasia (ARVD) or non compaction
结局指标
主要结局
functional exercise capacity
时间窗: one year
assessment of functional exercise capacity by performing six minutes walk test
reverse Right ventricular remodeling
时间窗: one year
reverse right ventricular remodeling detected by cardiac MRI and 2D echocardiography after
次要结局
未报告次要终点
研究者
Salah Eldin Mohammed Mostafa
Dr
Assiut University