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Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery

Pulmonary Hypertension Clinical Trial

Official title:
Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation

Clinical Trial Summary

The aim of this study is to determine the safety and efficiency of Remodulin®ï¼ˆTreprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.

Clinical Trial Description

PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02865733
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact
Status Completed
Phase Phase 3
Start date August 1, 2016
Completion date August 20, 2019
View Details
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