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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603888
First Posted: May 23, 2012
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01603888     History of Changes
Other Study ID Numbers: bnp1-HMO-CTIL
First Submitted: May 20, 2012
First Posted: May 23, 2012
Last Update Posted: September 17, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs