NCT01662037

Brief Summary

Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1.7 years

First QC Date

August 5, 2012

Last Update Submit

August 7, 2012

Conditions

Congenital Heart DefectsFunctional Single Ventricle

Keywords

Pulmonary vascular resistanceHeart defects, CongenitalReceptors, endothelinBosentan

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay and ICU stay

    12 months after Fontan operation

Secondary Outcomes (2)

  • Symptoms of increased PVR

    12 months after Fontan operation

  • WHO functional class

    12 months after Fontan operation

Study Arms (2)

Bosentan group

EXPERIMENTAL

Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Drug: Bosentan

Routinely group

NO INTERVENTION

Routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Interventions

BosentanDRUG

Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Also known as: Tracleer
Bosentan group

Eligibility Criteria

Age4 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Signed informed consent obtained from patient's legally acceptable representative.
  • Pediatric patients waiting for staged Fontan procedure with high risk of increased PVR after bidirectional cavopulmonary connection (BCPC)
  • Transpulmonary pressure gradiant (TPG) \> 10mmHg when the obstruction of anastomosis and lung problem were excluded.
  • With the diagnosis of high risk of increased PVR, such as associated with TAPVC, after pulmonary artery banding, after systemic to pulmonary shunt more than 6 months, and et al.
  • Diagnosed as increased PVR with catheterization.

You may not qualify if:

  • PAH associated with conditions other than those mentioned above, e.g., iPAH, PAH secondary to portal hypertension, HIV patient with opportunistic infection
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
  • AST and/or ALT \> 3 times the upper limit of normal ranges.
  • Hemoglobin concentration \< 75% the lower limit of normal ranges
  • Treatment or planned treatment with another investigational drug within 3 months of screening
  • Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of enrollment of this study
  • Known hypersensitivity to bosentan or any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zhuoming Xu, MD PhD

    Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attendant doctor, Department of thoracic and cardiovascular surgery

Study Record Dates

First Submitted

August 5, 2012

First Posted

August 10, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

CN(1)