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NCT03965351 · ClinicalTrials.gov registry record · Phase 4
TRPV2 Agonists in the Fontan Circulation
A Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT03965351: Completed Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03965351 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03965351, a Phase 4 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
There are currently very few proven pharmacologic options available for these patients. The recent discovery of transient receptor potential vanilloid (TRPV) channels, particularly TRPV2 channels, in the cardiovascular system is promising as a potential pathway for pharmacologic intervention for Fontan patients. Probenecid, a drug best known as a treatment for gout or as a penicillin adjunct, acts as a TRPV2 agonist and has recently become the subject of study as a model therapy for the treatment of cardiomyopathy due to its positive inotropic and lusitropic effects. The purpose of this pilot study is to determine if probenecid will improve magnetic resonance (MRI) parameters of systolic and/or diastolic dysfunction as well as associated symptoms in patients with a Fontan circulation. The investigators will quantitatively assess functional improvement with pre- and post-treatment cardiopulmonary exercise testing.
Primary Outcome
Determine if Fontan patients treated with probenecid for four weeks will experience increased systolic and diastolic function (as measured via standard and advanced MRI parameters) compared with four weeks of placebo. Participants will be assigned to either the placebo arm or study medication arm for the first four weeks. They will then undergo a four week wash out period. Finally, participants will be placed into the study arm that they were not assigned to in the first four weeks when they ret
Interventions
- OTHER Placebo
- DRUG Probenecid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 4 |
What the finished NCT03965351 record still lists
NCT03965351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03965351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03965351 about?
NCT03965351 is a clinical study titled "TRPV2 Agonists in the Fontan Circulation". There are currently very few proven pharmacologic options available for these patients. The recent discovery of transient receptor potential vanilloid (TRPV) channels, particularly TRPV2 channels, in the cardiovascular system is promising as a potential pathway for pharmacologic intervention for Fon...
What is the current status of trial NCT03965351?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2017-03-21. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03965351?
The interventions under investigation include: Placebo (OTHER), Probenecid (DRUG).
Who is sponsoring clinical trial NCT03965351?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03965351's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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