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NCT04901975 · ClinicalTrials.gov registry record · Phase 1
Fibrosis and the Fontan
A Phase 1 study of Single-ventricle, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 145
- Enrollment target
- 1
- Study location
NCT04901975: Recruiting Phase 1 study of Single-ventricle, sponsored by Children's Hospital of Philadelphia.
NCT04901975 is a Phase 1 study of Single-ventricle that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 145 participants, above the 78-participant average among 17 other Single-ventricle trials with a reported enrollment target (86% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04901975, a Phase 1 study of Single-ventricle, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 145 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by MRE for viscoelastic properties of the liver, primarily stiffness
Conditions Studied
Interventions
- DRUG Spironolactone
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT04901975 shows while recruiting
NCT04901975 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 17 other Single-ventricle trials with a reported enrollment target (86% higher).
The record links to 1 condition, with Single-ventricle appearing as the primary indexed condition, and to 1 intervention - of which Spironolactone is the first listed.
NCT04901975 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04901975 about?
NCT04901975 is a clinical study titled "Fibrosis and the Fontan". 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...
What is the current status of trial NCT04901975?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2021-02-11. Estimated completion is 2026-06-30.
What conditions does trial NCT04901975 study?
This clinical trial studies the following conditions: Single-ventricle.
What interventions are being tested in trial NCT04901975?
The interventions under investigation include: Spironolactone (DRUG).
Who is sponsoring clinical trial NCT04901975?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04901975 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Single-ventricle
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04901975's enrollment target sits among peer trials
145 5th of 17 higher than 13 of 17 other Single-ventricle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Single-ventricle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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