Pharmacological Test of Pulmonary Endothelium-dependent Vascular Reactivity to Acetylcholine in Pulmonary Arterial Hypertension With Congenital Cardiac Shunt Child and Adult
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Predictive performance of the reactivity test to the occurence of pulmonary arterial hypertension one year after the closure of the shunt.
研究概览
简要总结
The purpose of this study is to assess the predictive performance of the pulmonary vascular reactivity to acetylcholine, in the presence pulmonary arterial hypertension (estimated 1 year after the closure of the shunt).
详细描述
Pulmonary arterial hypertension (PAH) is an important cause of mortality and morbidity in patients with congenital heart disease with a shunt.
These congenital cardiac shunts are responsible for PAH, which evolves towards higher pulmonary vascular resistance if they are not closed early.
Patients with significant pulmonary flow and low pulmonary vascular resistance fully benefit from surgical shunt closure with complete disappearance of pulmonary hypertension after closure. In contrast, patients with low pulmonary flow and high pulmonary vascular resistance will have no benefit because they keep a deleterious pulmonary hypertension after closure of the shunt.
In certain situations, especially late discovery of heart disease, the issue of operability of these patients is crucial because closing the shunt inappropriately worsens the spontaneous prognosis. Currently, in case of doubt on the operability, there are several clinical and hemodynamic criteria used empirically, but their predictive value is uncertain.
It is therefore necessary to stratify patients into operable and inoperable groups to improve their overall outcome after surgery.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient child or adult, (regardless of age and weight) , which presents with heart disease with a shunt,
- •Patient who requires, during current care, a hemodynamic exploration by catheterization to assess pulmonary vascular resistance (due to doubt on the operability of the patient on the usual clinical and echo cardiographic data) .
- •Informed consent signed by the patient or at least one holder of parental authority, and the investigator
- •Patient affiliated or benefiting from a social security scheme
排除标准
- •Patient with a specific treatment for PAH (the prostacyclin derivatives, antagonists of endothelium receptors and inhibitors of phosphodiesterase 5).
- •Patient participating in another research with exclusion period
- •Known allergy to acetylcholine or adenosine
- •Contraindication to the use of KRENOSIN (adenosine)
- •atrioventricular block second or third degree, with the exception of patients with cardiac pacemaker.
- •dysfunction sinoatrial (the headset disease) except patients with a pacemaker
- •chronic obstructive pulmonary disease with bronchospasm (eg bronchial asthma)
- •long QT Syndrome
- •severe arterial hypotension
- •known adenosine hypersensitivity
- •Pregnant or patient of childbearing potential not using an effective contraception
结局指标
主要结局
Predictive performance of the reactivity test to the occurence of pulmonary arterial hypertension one year after the closure of the shunt.
时间窗: 1 year +/- 2 months
Evaluated in patient with "shunt closed" by : * the area under the ROC curve. * the parameter of interest is the Doppler flow velocity in m / s in endothelium-dependent vasodilation by acetylcholine relative to the speed in m / s at maximum vasodilatation (adenosine + in nitric oxide (NO) inhalation) * presence or absence of PAH one year after closure of the shunt will be evaluated by a conventional cardiac catheterization
次要结局
- Nature and frequency of adverse events(1 year +/- 2 months)
- occurrence of pulmonary hypertension.(1 year +/- 2 months)
- Characteristic of the distribution of test of reactivity in the population "shunt unclosed"(1 year +/- 2 months)