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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT01603888
Collaborator
(none)
60
1
53.9
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

  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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hadassah Medical Organization Jerusalem Israel

Sponsors and Collaborators

  • Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01603888
Other Study ID Numbers:
  • bnp1-HMO-CTIL
First Posted:
May 23, 2012
Last Update Posted:
Nov 28, 2017
Last Verified:
Aug 1, 2017
Keywords provided by Hadassah Medical Organization
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2017