Actively Recruiting
Fibrosis and the Fontan
Led by Children's Hospital of Philadelphia · Updated on 2025-06-08
145
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fibrosis and the Fontan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 6 years with single ventricle heart condition
- Scheduled to undergo Fontan operation at Children's Hospital of Philadelphia
- Single left or single right ventricle diagnosis
- Parents or guardians able to sign informed consent
- Controls: Children aged 1 to 6 years with normal heart and liver function undergoing MRI for clinical reasons
- Participants previously on study drug for 6 weeks or less and switching to observational group with consent
- Participants in other approved interventional studies with consent
You will not qualify if you...
- Any condition deemed harmful by the child's physician for study participation
- Contraindications for sedated cardiac MRI (e.g., pacemaker presence)
- Current use of spironolactone, eplerenone, or related medications
- Participation in other studies that could affect results or are not approved by the principal investigator
- For drug group: hyperkalemia, Addison disease, use of enalapril or angiotensin receptor blockers, hypersensitivity to spironolactone, or severe renal insufficiency (eGFR <30 mL/min/1.73 m2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19130
Actively Recruiting
Research Team
M
Mark Fogel, MD
CONTACT
C
Cassandra L Giner, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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