Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Membrane ductance (Dm) correlated with VO2max
研究概览
简要总结
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.
There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.
The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).
Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.
Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.
The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age > 8 years- female and male patients
- •Heart-rate exercise tolerance test planned in the usual patient's follow-up
- •Congenital heart disease: single ventricle with Fontan circulation or bicavo-bipulmonary bypass or systemic right ventricle or pulmonary failure
排除标准
- •Chronic or acute intercurrent respiratory disease
- •In exclusion period in relation with another trial or for
- •Participation to another study
- •Patient doesn't benefit from an insurance disease regimen
- •Pregnant woman or breast-feeding, law-protected person, vulnerable person
研究组 & 干预措施
Patient suffering from complex congenital heart disease
干预措施: Double pulmonary diffusing (Other)
结局指标
主要结局
Membrane ductance (Dm) correlated with VO2max
时间窗: at the time of evaluation at rest (15 minutes before exercise)
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
次要结局
- capillary pulmonary recruitment during exercise correlated with VO2max. (capillary pulmonary volume 3 minutes after the end of a maximal exercise minus capillary pulmonary volume at rest)(at the time of evaluation at rest (15 minutes before exercise) and 3 minutes after the end of a maximal exercise)
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with electrocardiographic parameters(at the time of evaluation at rest (15 minutes before exercise))
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with electrocardiographic parameters(3 minutes after the end of a maximal exercise)
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with electrocardiographic parameters(10 minutes after the end of a maximal exercise)
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max(at the time of evaluation at rest (15 minutes before exercise))
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)(at the time of evaluation at rest (15 minutes before exercise))
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with VO2max(3 minutes after the end of a maximal exercise)
- diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)(3 minutes after the end of a maximal exercise)
- parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with VO2max(10 minutes after the end of a maximal exercise)
- diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)(10 minutes after the end of a maximal exercise)