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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Remodulin
distilled water
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring Remodulin®, pulmonary vascular resistance, univentricular physiology

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Remodulin Injection

    Distilled water group

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    The primary end point is a composite variable
    consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance

    Secondary Outcome Measures

    Change from base line of pulmonary hemodynamic measurements
    Pp/Ps reduce >10% or TPG≤6mmHg.

    Full Information

    First Posted
    August 1, 2016
    Last Updated
    October 26, 2020
    Sponsor
    Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02865733
    Brief Title
    Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
    Official Title
    Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    August 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension
    Keywords
    Remodulin®, pulmonary vascular resistance, univentricular physiology

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Remodulin Injection
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Distilled water group
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Remodulin
    Other Intervention Name(s)
    Treprostinil Injection
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    distilled water
    Other Intervention Name(s)
    placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The primary end point is a composite variable
    Description
    consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance
    Time Frame
    the first 48 hours after Remodulin used
    Secondary Outcome Measure Information:
    Title
    Change from base line of pulmonary hemodynamic measurements
    Description
    Pp/Ps reduce >10% or TPG≤6mmHg.
    Time Frame
    baseline and 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: After Fontan procedure, the criteria should be met mPAP greater than 15 mmHg TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis) Exclusion Criteria: After Fontan surgery : Severe arrhythmia led to low cardiac output Platelets smaller than 50,000*109/L and obvious bleeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhuoming Xu, M.D.,Ph,D.
    Organizational Affiliation
    Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34430604
    Citation
    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.
    Results Reference
    derived

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

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