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OpenTrials
Completed

NCT Number: NCT02746029

Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

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.

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Key information

Age range

4 week–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneously discovered heart murmur at general practitioner's office

Exclusion criteria

  • Known cardiac disease
  • Other chronic or acute disorder
  • Medications

Treatment and study plan

Clinical examination

Other

Primary outcomes

  1. Number of patients with any congenital heart disease as assessed by echocardiography

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Acronym: CAMUS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2016
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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