Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

NCT02746029 | Completed

• 1 other identifier: CAMUS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  1 day

Study Arms (1)

Children with cardiac murmur

Other: Clinical examination

Interventions

Clinical examination OTHER

Children with cardiac murmur

Eligibility Criteria

• Age: 4 Weeks - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children consecutively referred to Akerhus University Hospital for spontaneously discovered cardiac murmur in general practice.

You may qualify if:

• Spontaneously discovered heart murmur at general practitioner's office

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Vegard Wyller

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 21, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

NO (1)