CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
Probenecid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03965351
NCT03965351Phase 4Completed

TRPV2 Agonists in Fontan Circulation Patients

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 29, 2019·Updated Jul 9, 2021

In Brief

A Phase 4 clinical trial evaluating Probenecid and Placebo for Fontan. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFontan
CountriesUnited States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 29, 2019
Enrollment StartMar 21, 2017
Primary CompletionJun 30, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.1 years ago

Interventions

Probeneciddrug

This is a cross-over pilot study where participants will receive both the study medication (probenecid), as well as a placebo to see if the study medication improves magnetic resonance parameters of systolic and diastolic dysfunction that occurs in the Fontan population.

Placeboother

placebo