Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

NCT ID: NCT02746029

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with cardiac murmur

Clinical examination

Intervention Type: OTHER

Interventions

Clinical examination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Spontaneously discovered heart murmur at general practitioner's office

Exclusion Criteria

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Vegard Wyller

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vegard Wyller

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, Norway

Countries

Norway

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CAMUS

Identifier Type: -

Identifier Source: org_study_id