- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138708
Evaluation of the Pulmonary Vascular Reactivity Test in Patients With Pulmonary Arterial Hypertension and a Cardiac Shunt (ReVAch)
Pharmacological Test of Pulmonary Endothelium-dependent Vascular Reactivity to Acetylcholine in Pulmonary Arterial Hypertension With Congenital Cardiac Shunt Child and Adult
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shunt closed
patients with heart disease and shunt who, following hemodynamic exploration, will be selected for closure of their shunt
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 :
|
1 year +/- 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
occurrence of pulmonary hypertension.
Time Frame: 1 year +/- 2 months
|
1 year +/- 2 months
|
Nature and frequency of adverse events
Time Frame: 1 year +/- 2 months
|
1 year +/- 2 months
|
Characteristic of the distribution of test of reactivity in the population "shunt unclosed"
Time Frame: 1 year +/- 2 months
|
1 year +/- 2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension, Pulmonary
- Hypertension
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Cholinergic Agonists
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
- Acetylcholine
Other Study ID Numbers
- P120910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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