Molecular Forms of Plasma and Urinary B-type Natriuretic Peptide and Its N-terminal Prohormone in Health and Disease in Pediatric Cardiology
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedNovember 28, 2017
August 1, 2017
2 years
May 20, 2012
November 26, 2017
Conditions
Keywords
Outcome Measures
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.
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
one year
Study Arms (3)
healthy newborns, BNP, NT-proBNP
healthy newborns
infants, BNP, NT-proBNP
infants
children with heart disease, BNP, NT-proBNP
children with heart disease
Interventions
Eligibility Criteria
Normal newborn infants and premature babies. Infants and children with significant heart disease.
You may qualify if:
- Healthy newborn infants with normal pregnancy and delivery
- Premature infants
- Infants and children with heart disease who have NT-proBNP levels taken as part of cardiac evaluation
You may not qualify if:
- Patients with non cardiac disease (renal, hepatic)
- Patients with acute urinary disease or other acute non-cardiac diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2012
First Posted
May 23, 2012
Study Start
January 1, 2013
Primary Completion
January 1, 2015
Study Completion
July 1, 2017
Last Updated
November 28, 2017
Record last verified: 2017-08