Fibrosis and the Fontan (NCT04901975) | Clinical Trial Compass
RecruitingPhase 1/2
Fibrosis and the Fontan
United States145 participantsStarted 2021-02-11
Plain-language summary
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics. This project investigates the response to acute imposition of Fontan hemodynamics by examining the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion along with a pilot trial of the antifibrotic agent, spironolactone, to prevent these consequences and to determine if MRI can discern these differences. The combination of serum biomarkers and MRI form a powerful non-invasive tool in putting together this complicated web of dysfunction.
Who can participate
Age range
1 Year – 6 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:
* Single Ventricle (SV) Patients
Cohort 1 (Observational Group - no study medication):
* Subjects between 1 and ≤ 6 years of age of either gender.
* Either single left or single right ventricle.
* Subjects who are scheduled to undergo a Fontan operation at CHOP.
* Parents signing informed consent.
Cohort 1A (formerly part of study drug group who wish continued participation in the observational group):
* Subjects who were enrolled in this study in Cohort 2 and are either non-compliant with the medication, no longer want to take the medication, or have an AE that requires them to stop the medication, and patient's family would like to continue participation
* Patients were on study medication for 6 weeks or less.
* The principal investigator deems it appropriate for the patient to switch to the observational arm.
* Patients signing the observational informed consent form.
Cohort 1B (observational group - in other studies with intervention):
* Subjects between 1 and ≤6 years of age of either gender.
* Either single left or single right ventricle.
* Subjects who are planned to undergo a Fontan operation at CHOP.
* Patients in other interventional studies approved by principal investigator.
* Patients signing the observational informed consent form.
Cohort 2 (study drug Group - spironolactone):
* Subjects between 1 and ≤ 6 years of age of either gender.
* Either single left or single right ventricle.
* Subjects who are scheduled to undergo a Fontan op…
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
Liver elastography by MRE prior to and after Fontan
Timeframe: up to 1 year
2
Liver elastography by T1rho prior to and after Fontan
Timeframe: up to 1 year
3
Heart tissue characterization by T1 mapping prior to and after Fontan
Timeframe: up to 1 year
4
Heart tissue characterization prior to and after Fontan