The Role of the Pulmonary Vasculature in the Fontan Circulation (NCT02414321) | Clinical Trial Compass
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The Role of the Pulmonary Vasculature in the Fontan Circulation
Netherlands20 participantsStarted 2015-06
Plain-language summary
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients.
Objectives:
* Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.
* Characterization of structural properties of small pulmonary arteries.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Fontan group
* written informed consent
* Clinical indication for cardiac catheterization
Control group
* written informed consent
* Clinical indication for right heart catheterization
* Absence of pulmonary vascular disease
* Normal pulmonary vascular hemodynamic profile
Exclusion criteria:
Fontan group
* Standard exclusion criteria for cardiac catheterization
* Obstruction in Fontan conduit
* Inability to measure a reliable cardiac index and PVR (rhythm instability, hemodynamic or anatomic reasons)
Control Group
\- No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
vasodilatation
Timeframe: change in indexed cardiac output between baseline and after 10 minutes of pulmonary vasodilatation at heart catheterization
2
number of intimal lesions in small pulmonary arteries