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

Completed

• Conditions: Heart Disease; Health
• Interventions: Other: no intervention

• Registration Number: NCT01603888
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-20
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Study Start: 2013-01
• Primary Completion: 2015-01
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
infants, BNP, NT-proBNP	no intervention	infants
healthy newborns, BNP, NT-proBNP	no intervention	healthy newborns
children with heart disease, BNP, NT-proBNP	no intervention	children with heart disease

Primary Outcome Measures

Name	Time	Method
molecular forms of BNP in healthy newborns, infants and children with heart disease.	one year	Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

Secondary Outcome Measures

Name	Time	Method
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	one year	Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel