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

NCT02865733 | Completed Phase 3 DMC

• 1 other identifier: SJTUMS-201607
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Keywords

Remodulin®; pulmonary vascular resistance; univentricular physiology

Outcome Measures

Primary Outcomes (1)

• The primary end point is a composite variable

  consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance

  the first 48 hours after Remodulin used

Secondary Outcomes (1)

• Change from base line of pulmonary hemodynamic measurements

  baseline and 48 hours

Study Arms (2)

Remodulin Injection

EXPERIMENTAL

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

Drug: Remodulin

Distilled water group

PLACEBO COMPARATOR

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

Drug: distilled water

Interventions

Remodulin DRUG

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.

Also known as: Treprostinil Injection

Remodulin Injection

distilled water DRUG

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.

Also known as: placebo

Distilled water group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• After Fontan procedure, the criteria should be met
• mPAP greater than 15 mmHg
• TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)

You may not qualify if:

• After Fontan surgery :
• Severe arrhythmia led to low cardiac output
• Platelets smaller than 50,000\*109/L and obvious bleeding

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Related Publications (1)

• Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188.

  PMID: 34430604 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhuoming Xu, M.D.,Ph,D.

  Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief cadiologist,Director of Cardiac intensive Care Unit

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: August 20, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10