drugset / Trial / NCT04901975
Fibrosis and the Fontan
Phase 1/2
Completed
98 enrolled
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-02-11
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spironolactone | Small molecule | 3 mg/kg | — |