Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease

NCT04815577 | Completed

• 1 other identifier: RECHMPL19_0476
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. After focusing on survival, more attention is being given to health-related quality of life and secondary prevention in this population where warning signals are launched on the risk of sedentary lifestyle, obesity, cardiovascular risk 1. The cardiopulmonary exercise test (CPET), which is a non-invasive and dynamic examination, is becoming the gold standard to the follow-up 2 of these patients by allowing to quantify disease severity, to evaluate the quality of life 3, to give important prognostic information on functional capacity and haemodynamic response 4, to facilitate a safe decision-making when prescribing exercise programmes and sport participation for these children with CHD 5. In this context, in a cross-sectional study from 2010 to 2015, the investigators evaluated the cardiopulmonary fitness of children with CHD by comparing them with healthy children 6. In this study, 496 children with CHD compared to 302 healthy children were included. It showed that maximum oxygen uptake (VO2max) and ventilatory anaerobic threshold (VAT) are decreased in CHD children compared to healthy children, clinical determinants of decreased VO2max have been defined for CHD children. This study was proposed, despite the cross-sectional nature, an average decrease in annual VO2max (0,84 ml/kg/min per year) to make pediatric and congenital cardiologist aware of the need to a regular follow up for these patients. In this new study, the main objective was to know the real evolution of VO2max in these patients from this same cohort, with a longitudinal design, by collecting a new CPET carried out between 2015 and 2020 and compared these results to healthy pediatric population. The secondary objectives were: to know the evolution of the VAT, to define the clinical determinants in relation to the annual decrease of the VO2max. And to describe the population lost to follow-up in this retrospective study which represents current practice.

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; VO2max; Cardio-pulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• to give the annual evolution in VO2max for patients with CHD compared to control children

  comparison of the VO2max value in ml/kg/min between point 1 and point 2 (greater than 1 year) and report the value per year. These results will be compared to evolution of VO2max in controlled children.

  more than 1 year (maximum 8 years)

Secondary Outcomes (3)

• to give the annual evolution in VAT for patients with CHD compared to control children

  more than 1 year (maximum 8 years)

• correlation between clinical determinants and annual decrease of the VO2 max in the CHD group

  more than 1 year (maximum 8 years)

• description of the population lost to follow-up in this retrospective study which represents current practice

  more than 1 year (maximum 8 years)

Study Arms (2)

CHD group

The CHD group is made up of the children included in the first study. From these 496 children with CHD, children with a second CPET more than one year from the first referral CPET were included. If several CPETs were performed in the follow-up, we retain the most distant CPET from the first, excluding the CPETs that were performed after a cardiopulmonary rehabilitation program implemented in the region in 2018. The group corresponding to the first CPET was called. Among the initial 496 children, if patients had not had a second CPET, the cause was indicated. As a reminder, the patients included in the initial study were aged 5-18 years old and they were referred by their paediatric cardiologists to one of the two CPET laboratories after their annual medical check-up. The anatomical and clinical classification of congenital heart diseases was used to define the type of malformation. The demographic, clinical, echocardiographic data were collected during the first CPET.

Controle

The controle Group consisted of children referred for nonsevere functional symptom linked to exercise (murmur, palpitations or dyspnea) or for a medical sports certificate. We included controlled children from 2015 to 2020 period who will be added to the controlled patients of the initial study. These patients only had one CPET.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Children with congenital heart disease with 2 CPET separated at least by 1 year * Controlled children with completely normal check-up, including physical examination, ECG, echocardiography and spirometry

You may qualify if:

• \- children with CHD included in the first study carried out from 2010 to 2015 6 and who have had at least 1 CPET 1 year after the first.
• children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate.
• completely normal check-up, including physical examination, ECG, echocardiography and spirometry.

You may not qualify if:

• Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal)
• Children with any medical treatment
• Children requiring any further specialised medical consultation

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (2)

• Amedro P, Mura T, Matecki S, Guillaumont S, Requirand A, Jeandel C, Kollen L, Gavotto A. Use of new paediatric VO2max reference equations to evaluate aerobic fitness in overweight or obese children with congenital heart disease. Eur J Prev Cardiol. 2023 Nov 30;30(17):1865-1873. doi: 10.1093/eurjpc/zwad201.

  PMID: 37314435 BACKGROUND

• Gavotto A, Ladeveze M, Avesani M, Huguet H, Guillaumont S, Picot MC, Requirand A, Matecki S, Amedro P. Aerobic fitness change with time in children with congenital heart disease: A retrospective controlled cohort study. Int J Cardiol. 2023 Jan 15;371:140-146. doi: 10.1016/j.ijcard.2022.09.068. Epub 2022 Sep 29.

  PMID: 36181952 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Arthur GAVOTTO, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Pascal AMEDRO, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 20, 2021
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

FR (1)