Acute Effects of Inhaled Treprostinil in Fontan Patients
Status:
Terminated
Trial end date:
2018-09-21
Target enrollment:
Participant gender:
Summary
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.