Biomarkers of Pediatric Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969925
• Other study ID #: Ahmed Mahny
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 2, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Ahmed A Mohammed, Dr.
• Phone: +18677791
• Email: ahmedna1712[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2, 2024
• Est. primary completion date: September 2, 2024
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• new biomarkers for heart failure
assess efficacy of new biomarkers for heart failure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Ali Mahny	Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure	accuarcy of serum level of Neutrophil gelatinase-associated lipocalin in heart failure	one year