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

What Was Tested

This registered not phased trial tested BNP (Nesiritide) for heart repair: after heart attack, heart failure & enlarged heart.

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

It had two arms (groups): rhBNP Group (experimental) and Placebo Group (placebo comparator).

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 actual participants took part.

It was open to people of any sex aged from 1 Month up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent obtained from patient's legally acceptable representative. Pediatric patients after Repair of Tetralogy Of Fallot.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the heart repair: after heart attack, heart failure & enlarged heart participants and researchers unaware of who received BNP (Nesiritide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-09-01 with completion listed for 2017-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes from Baseline in BNP and CVP after the infusion of rhBNP (time frame: 12 months after operation of Tetralogy Of Fallot).

It also tracked 1 secondary outcome, for example Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of BNP (Nesiritide) in 120 people with heart repair: after heart attack, heart failure & enlarged heart.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, Heart repair: after heart attack, heart failure & enlarged heart research.