Evaluation of the Pulmonary Vascular Reactivity Test in Patients With Pulmonary Arterial Hypertension and a Cardiac Shunt (ReVAch)
|ClinicalTrials.gov Identifier: NCT02138708|
Recruitment Status : Suspended
First Posted : May 15, 2014
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension With Congenital Cardiac Shunt||Other: Pharmacological test of pulmonary endothelial||Not Applicable|
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.
In this research project we propose to assess the predictive performance of the pulmonary vascular reactivity to acetylcholine test on the presence of elevated PAH 1 year after the closure of the shunt. This reactivity test will be evaluated on a population of patients for whom the decision of the surgical closure of the shunt has been adjudicated on the basis of explorations and usual tests (and therefore blind to the knowledge of the result of the reactivity test). The test in this study is designed with repeated injections and increasing doses with a continuous flow of acetylcholine in the left lower lobe of the pulmonary artery. The last injection consisted with adenosine with inhaled O2/NO (potentiating effect) for maximum vasodilatation. The parameter of interest is the Doppler flow velocity in the pulmonary artery endothelium-dependent vasodilation by acetylcholine relative to the speed at maximum vasodilatation (adenosine + in nitric oxide (NO) inhalation)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacological Test of Pulmonary Endothelium-dependent Vascular Reactivity to Acetylcholine in Pulmonary Arterial Hypertension With Congenital Cardiac Shunt Child and Adult|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||April 2018|
Experimental: Shunt closed
patients with heart disease and shunt who, following hemodynamic exploration, will be selected for closure of their shunt
Other: Pharmacological test of pulmonary endothelial
- Predictive performance of the reactivity test to the occurence of pulmonary arterial hypertension one year after the closure of the shunt. [ Time Frame: 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
- occurrence of pulmonary hypertension. [ Time Frame: 1 year +/- 2 months ]
- Nature and frequency of adverse events [ Time Frame: 1 year +/- 2 months ]
- Characteristic of the distribution of test of reactivity in the population "shunt unclosed" [ Time Frame: 1 year +/- 2 months ]