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CompletedNCT01603888Updated Nov 28, 2017

Molecular Forms of Plasma and Urinary B-type Natriuretic Peptide and Its N-terminal Prohormone in Health and Disease in Pediatric Cardiology

An observational study in Heart Disease and Health, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Hadassah Medical Organization · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
Up to 18 Years
Sex
All
01

Study summary

B-type natriuretic Peptide (BNP) is a cardiac hormone secreted from the cardiac myocytes in response to volume load. Plasma levels of BNP, as measured by immunoassay methods, are elevated in patients with heart diseases. However, the biological effects of BNP are blunted in heart failure and other cardiac conditions. Moreover, the peptide levels are also elevated in non cardiac conditions such as the neonatal period, sepsis and renal failure. Recent investigations suggest alteration of the peptide molecular structure in heart failure. These alterations may explain, at least partially, the reduced biological activities of BNP in heart failure.

Immunoreactive BNP and NT-proBNP have been identified in human urine. It has been suggested that urinary BNP correlates with plasma BNP, and may serve as a non-invasive measure for this cardiac marker. It is unclear what BNP fractions are cleared in the urine in health and disease.

The aim of the proposed studies is to elucidate precisely the molecular form of BNP in various disease and specific physiological states in plasma and urine of infants and children.

02

Conditions studied

  • Heart Disease
  • Health

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Keywords

  • children with heart disease
  • infants
  • healthy newborns
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 60 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal newborn infants and premature babies. Infants and children with significant heart disease.

Inclusion criteria

  1. Healthy newborn infants with normal pregnancy and delivery
  2. Premature infants
  3. Infants and children with heart disease who have NT-proBNP levels taken as part of cardiac evaluation

Exclusion criteria

Exclusion Criteria:

  1. Patients with non cardiac disease (renal, hepatic)
  2. Patients with acute urinary disease or other acute non-cardiac diseases.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)

Groups and cohorts

  • healthy newborns, BNP, NT-proBNP

    healthy newborns

    Other: no intervention

  • infants, BNP, NT-proBNP

    infants

    Other: no intervention

  • children with heart disease, BNP, NT-proBNP

    children with heart disease

    Other: no intervention

Interventions

  • Otherno intervention
06

What researchers measure

Primary outcomes

  1. molecular forms of BNP in healthy newborns, infants and children with heart disease.

    Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

    Time frame: one year

Secondary outcomes

  1. BNP presence and define its molecular forms in urine of healthy newborns,infants and children with heart disease. BNP presence and define its molecular forms in urine of healthy newborns and infant and children with heart disease. BNP presence and

    Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

    Time frame: one year

07

Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01603888
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
May 23, 2012
Start date
Jan 2013
Primary completion
Jan 2015
Completion
Jul 2017
Last update
Nov 28, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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