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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01603888
Enrollment
60
Registered
2012-05-23
Start date
2013-01-31
Completion date
2017-07-31
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Heart Disease

Keywords

children with heart disease, infants, healthy newborns

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.

Interventions

OTHERno intervention

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
molecular forms of BNP in healthy newborns, infants and children with heart disease.one yearQuantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

Secondary

MeasureTime frameDescription
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 andone yearQuantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.

Countries

Israel

Outcome results

None listed

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