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

Phase 3

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: distilled water; Drug: Remodulin

• Registration Number: NCT02865733
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed 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 Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Primary Completion: 2018-12-31
• Study Completion: 2019-08-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distilled water group	distilled water	Drug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours
Remodulin Injection	Remodulin	Drug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours

Primary Outcome Measures

Name	Time	Method
The primary end point is a composite variable	the first 48 hours after Remodulin used	consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance

Secondary Outcome Measures

Name	Time	Method
Change from base line of pulmonary hemodynamic measurements	baseline and 48 hours	Pp/Ps reduce \>10% or TPG≤6mmHg.