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

November 26, 2017 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 20, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 26, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bnp1-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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