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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: distilled water; Drug: Remodulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02865733

SJTUMS-201607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

Remodulin Injection

Experimental group

Description:

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

Treatment:

Drug: Remodulin

Distilled water group

Placebo Comparator group

Description:

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

Treatment:

Drug: distilled water