Heart FailureNCT05969925
Biomarkers of Pediatric Heart Failure
An observational study of Heart Failure, run by Ahmed Ali Mahny.
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 Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- new biomarkers for heart failure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 2 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- Child
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
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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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].
- Conditions
- Heart Failure
- Being tested
- new biomarkers for heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new biomarkers for heart failureDiagnostic test
assess efficacy of new biomarkers for heart failure
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure
accuarcy of serum level of Neutrophil gelatinase-associated lipocalin in heart failure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion2 Sep 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Ali Mahny
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Ahmed Ali Mahny, Assiut University
- Investigators
- Ahmed A Moahmmed, Dr., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969925
- Sponsor's protocol ID
- Ahmed Mahny
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32888688
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Some Biomarkers Of Heart Failure In Children Attending Pediatric Cardiology Department Of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT05969925
- Acronym / sponsor ID
- Ahmed Mahny
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ahmed Ali MahnyUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 2 Sep 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new biomarkers for heart failureassess efficacy of new biomarkers for heart failure | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 32888688Watanabe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Moahmmed, Dr. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Ahmed Ali Mahny.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Mohammed, Dr. (+18677791, ahmedna1712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.