Lung vessel test for heart defect patients pulled before starting
NCT ID NCT02138708
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to see if a test using acetylcholine could predict whether people with congenital heart disease and high blood pressure in the lungs would develop worsening high blood pressure after surgery to close a heart shunt. The test would have measured how well the lung blood vessels relax. However, the study was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acetylcholine
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Jan 2016
An estimate. Start dates often move.
- Finished
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Mar 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.