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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02865733

Enrollment

Registered

2016-08-12

Start date

2016-08-01

Completion date

2019-08-20

Last updated

2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Remodulin®, pulmonary vascular resistance, univentricular physiology

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.

Interventions

DRUGRemodulin

After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.

DRUGdistilled water

After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026