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 range1 Year – 6 Years
SexALL
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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…
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