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

Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603888
• Other study ID #: bnp1-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: May 20, 2012
• Last updated: November 26, 2017
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health
• Heart Disease
• Heart Diseases

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	one year