Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941576

Enrollment

120

Registered

2013-09-13

Start date

2013-09-01

Completion date

2019-07-20

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

Congenital Heart Defects, Tetralogy Of Fallot

Keywords

Heart defects, Congenital, rhBNP, heart failure

Brief summary

The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

Detailed description

CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.

Interventions

DRUGrecombinant human brain natriuretic peptide (rhBNP)

Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.

DRUGPlacebo (0.9% sodium chloride)

Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

Inclusion criteria

* Signed informed consent obtained from patient's legally acceptable representative. * Pediatric patients after Repair of Tetralogy Of Fallot.

Exclusion criteria

* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements. * Treatment or planned treatment with another investigational drug within 3 months of screening. * Known hypersensitivity to bosentan or any of the excipients * cardiogenic shock and inclination of hypotension（SBP\< 60mmHg）.

Design outcomes

Primary

Measure	Time frame	Description
Changes from Baseline in BNP and CVP after the infusion of rhBNP	12 months after operation of Tetralogy Of Fallot	we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure.

Secondary

Measure	Time frame	Description
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen	12 months after operation of Tetralogy Of Fallot	we evaluate the renal function through the volume of urine out and numerical value of serum creatinine and blood urea nitrogen.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026