Biomarkers of Pediatric Heart Failure

July 31, 2023 updated by: Ahmed Ali Mahny

Study of Some Biomarkers Of Heart Failure In Children Attending Pediatric Cardiology Department Of Assiut University Children Hospital

Heart failure (HF) is a clinical syndrome where the heart is unable to pump the blood required to meet the metabolic demands of the body. Heart failure in children can result from a variety of structural or functional cardiac disorders with subsequent failure of the ventricles to fill with or eject blood

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac biomarkers are useful as diagnostic and prognostic tools, especially in patients with atypical signs and symptoms. High rate of complication in HF led to the search for suitable cardiac biomarker that diagnose heart failure as early as possible, predict outcome, reflect response to treatment and help in staging of heart failure and determine risk (6) . In pediatrics, biomarkers of heart failure are particularly important for the early identification and risk stratification of patients with systemic diseases and associated risk for early development of heart failure. Good biomarkers have the following characteristics: high sensitivity and specificity, the possibility of simultaneous processing of many samples, short analysis time, low cost, and good clinical applications, thus predicting the risk of heart failure and the associated prognosis as well as the adequacy of monitoring [7].

. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 kDa protein covalently bound to matrix metalloproteinase-9 which was first isolated from neutrophils. It belongs to the lipocalin family, NGAL has been found to be elevated in both plasma and urine in patients with HF.(8) NGAL also acts as a growth and differentiation factor in the renal epithelium [9].

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study will be carried out in the children diagnosed with heart failure (HF) will be enrolled in this study. They will be choosen from those admitted at the Pediatric Cardiology Unit, Pediatric Department, Assiut University Children's Hospital in one year

Description

Inclusion Criteria Children from 1 month to 16 years old admitted to Assiut children University Hospital the Pediatric Cardiology unit with clinical manifestation of heart failure according to Ross classification either due to congenital or due to acquired heart disease will be enrolled in the study Exclusion Criteria Children with renal disease or failure, hepatic disease, pulmonary diseases will also excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure
Time Frame: one year
accuarcy of serum level of Neutrophil gelatinase-associated lipocalin in heart failure
one year

Collaborators and Investigators

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

Sponsor

Ahmed Ali Mahny

Collaborators

Assiut University

Investigators

  • Principal Investigator: Ahmed A Moahmmed, Dr., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 2, 2024

Study Completion (Estimated)

September 2, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahmed Mahny

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Heart Failure

Clinical Trials on new biomarkers for heart failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe