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

• Status: Completed
• Trial end date: 2019-08-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

After Fontan procedure, the criteria should be met

1. mPAP greater than 15 mmHg

2. TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)

Exclusion Criteria:

After Fontan surgery :

1. Severe arrhythmia led to low cardiac output

2. Platelets smaller than 50,000*109/L and obvious bleeding