Pulmonary Arterial Hypertension With Congenital Cardiac ShuntReVAchNCT02138708
Evaluation of the Pulmonary Vascular Reactivity Test in Patients With Pulmonary Arterial Hypertension and a Cardiac Shunt
A study testing Pharmacological test of pulmonary endothelial in people with Pulmonary Arterial Hypertension With Congenital Cardiac Shunt, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension With Congenital Cardiac Shunt
- What is being tested?
- Pharmacological test of pulmonary endothelial
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Pharmacological Test of Pulmonary Endothelium-dependent Vascular Reactivity to Acetylcholine in Pulmonary Arterial Hypertension With Congenital Cardiac Shunt Child and Adult
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).
Read the 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)
- Being tested
- Pharmacological test of pulmonary endothelial
- Keywords
- Pulmonary arterial hypertension,, congenital heart disease,, heart shunt,, acetylcholine, Pharmacological test of pulmonary vascular reactivity (acetylcholine) in
- Medical subject headings
- Pulmonary Arterial Hypertension, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological test of pulmonary endothelialOther
Also called Before any shunt closure operation, the patients will have a the endothelium-dependant reactivity test., This includes for the same patient :, - Implementation of Doppler probe in the lower left lobe guided in one probe 5 catheter guide right coronary 5 Fr, - then control infusion G5%
| Study group | Role | What they receive |
|---|---|---|
| Shunt closed | Experimental | patients with heart disease and shunt who, following hemodynamic exploration, will be selected for closure of their shunt Receives: Other: Pharmacological test of pulmonary endothelial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of the reactivity test to the occurence of pulmonary arterial hypertension one year after the closure of the shunt.
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
Measured: 1 year +/- 2 months
Secondary outcomes (3)
occurrence of pulmonary hypertension.
Measured: 1 year +/- 2 months
Nature and frequency of adverse events
Measured: 1 year +/- 2 months
Characteristic of the distribution of test of reactivity in the population "shunt unclosed"
Measured: 1 year +/- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2016 (estimated)
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Lack of financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension With Congenital Cardiac ShuntStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138708
- Sponsor's protocol ID
- P120910
- Acronym
- ReVAch
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2014
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Test of Pulmonary Endothelium-dependent Vascular Reactivity to Acetylcholine in Pulmonary Arterial Hypertension With Congenital Cardiac Shunt Child and Adult
- ClinicalTrials.gov ID
- NCT02138708
- Acronym / sponsor ID
- ReVAch / P120910
- Keywords
- Pulmonary arterial hypertension,, congenital heart disease,, heart shunt,, acetylcholine, Pharmacological test of pulmonary vascular reactivity (acetylcholine) in
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2016 (estimated)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shunt closed | Experimental | Other: Pharmacological test of pulmonary endothelialpatients with heart disease and shunt who, following hemodynamic exploration, will be selected for closure of their shunt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological test of pulmonary endothelialAlso: Before any shunt closure operation, the patients will have a the endothelium-dependant reactivity test., This includes for the same patient :, - Implementation of Doppler probe in the lower left lobe guided in one probe 5 catheter guide right coronary 5 Fr, - then control infusion G5% | Other | Shunt closed |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological test of pulmonary endothelial in people with Pulmonary Arterial Hypertension With Congenital Cardiac Shunt, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.