MedDataX Logo

Bosentan Therapy in Children With Functional Single Ventricle

NCT ID: NCT01662037

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Increased pulmonary vascular resistance (PVR) is a serous issues in children with functional single ventricle during the staged operative period. The purpose of this study is to investigate if Bosentan therapy can improve the survival and life quality after staged Fontan procedure in the children with high risk of increased PVR.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Defects Functional Single Ventricle

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulmonary vascular resistance Heart defects, Congenital Receptors, endothelin Bosentan

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bosentan group

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.

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

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.

Routinely group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bosentan

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tracleer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

4 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Limin Zhu

Attendant doctor, Department of thoracic and cardiovascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhuoming Xu, MD PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SJTUMS-20120314

Identifier Type: -

Identifier Source: org_study_id