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Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

NCT02746029 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-05-30

No results posted yet for this study

Summary

Heart murmurs are commonly discovered in young children during clinical encounters in general practice. Heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. Thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). However, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. The prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %.

It would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office:

* Healthy children would not be exposed to comprehensive cardiac examination
* The burden on the family would subside.
* Scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease.

The primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac ultrasound examination in general practice; b) To establish age-adjusted reference range for cardiac markers in children, and c) To explore aspects of cardiovascular physiology in children.

The investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for assessment of heart murmurs. All participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. The value of possible predictors will be assessed through the construction of Receiver Operating Characteristics (ROC) curves, and calculation of negative predictive value.

Conditions

  • Congenital Heart Disease

Interventions

OTHER

Clinical examination

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Vegard Wyller · University Hospital, Akershus

Eligibility

Min Age
4 Weeks
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Norway

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02746029 on ClinicalTrials.gov