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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01603888
First received: May 20, 2012
Last updated: September 15, 2013
Last verified: September 2013
  Purpose

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 Intervention
Heart Disease
Health
Other: no intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • molecular forms of BNP in healthy newborns, infants and children with heart disease. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.


Secondary Outcome Measures:
  • 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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quantification of the specific molecular forms will be performed by liquid chromatography coupled to mass spectrometry.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal newborn infants and premature babies. Infants and children with significant heart disease.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603888

Contacts
Contact: Amiram Nir, Prof. 972-2-6777355 amiramn@ekmd.huji.ac.il
Contact: Anat Daskal, Msc 972-2-6779549 anatd@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lamberg    972-267711111    hadasl@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01603888     History of Changes
Other Study ID Numbers: bnp1-HMO-CTIL
Study First Received: May 20, 2012
Last Updated: September 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
children with heart disease
infants
healthy newborns

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014