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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 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03965351
The ClinicalTrials.gov registry entry for NCT03965351 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03965351 reports 0 study locations.
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.
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