This trial is terminated!
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More info
You can access this
clinical trial
if you have
Congenital Heart Disease
and you are
over 18
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.

Provided treatments

  • Drug: Treprostinil
  • Drug: Placebo
Tris trial is registered with FDA with number: NCT02769624. The sponsor of the trial is Children's Hospital Medical Center, Cincinnati and it is looking for 15 volunteers for the current phase.
Official trial title:
A Randomized, Placebo-Controlled Pilot Study to Determine the Acute Effects of Inhaled Treprostinil on Exercise, Vascular Function, and Exercise Induced Liver Stiffness in Fontan Patients