Biomarkers of Pediatric Heart Failure

NCT ID: NCT05969925

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-09-02

Brief Summary

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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

Detailed Description

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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 \[9\].

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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new biomarkers for heart failure

assess efficacy of new biomarkers for heart failure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Ahmed Ali Mahny

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ali Mahny

Specialist, Pediatric Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed A Moahmmed, Dr.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Ahmed A Mohammed, Dr.

Role: CONTACT

+18677791

References

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Watanabe K, Shih R. Update of Pediatric Heart Failure. Pediatr Clin North Am. 2020 Oct;67(5):889-901. doi: 10.1016/j.pcl.2020.06.004. Epub 2020 Aug 11.

Reference Type BACKGROUND
PMID: 32888688 (View on PubMed)

Other Identifiers

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Ahmed Mahny

Identifier Type: -

Identifier Source: org_study_id

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