Cardiopulmonary fitness in children with congenital heart diseases versus healthy children

Abstract

ClinicalTrials.gov NCT01202916;Post-results.

Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV‐INHIBITION study design

“…univentricular heart), as defined by the Anatomic and Clinical Classification of Congenital Heart Defects (ACC‐CHD), and aged 15 years and above will be prospectively recruited in the participating centres during their regular follow‐up. In the current guidelines, patients with an SV usually require an annual check‐up, including a cardiology consultation, an electrocardiogram, a cardiac imaging examination (echocardiogram and/or cardiac magnetic resonance imaging), a blood test, a spirometry at rest, and a cardio‐pulmonary exercise test (CPET) . During the screening phase, patients with an SV referred for cardiac catheterization for heart failure, cyanosis, pre‐transplantation assessment, exudative enteropathy, bronchial casts, and/or liver disease will be identified.…”

“…As detailed in our previous multicentre CPET studies, exercise test procedures in all participating laboratories will be harmonized before the start of the study . All centres will use the same CPET cycle ergometer protocol, to obtain a homogeneous incremental overall duration between 8 and 12 min: a 1 min rest; a 3 min warm‐up (10 to 20 W) in increments of 10, 15, or 20 W each minute; a pedalling rate of 60 to 80 revolutions per minute; a 3 min active recovery (20 W); and a 2 min rest.…”

“…in submaximal exercise test), ventilatory anaerobic threshold (VAT) using Beaver's method, oxygen pulse (ratio VO 2 /heart rate), oxygen uptake efficiency slope (OUES), and minimal oxygen saturation (SpO 2 ), will be recorded. VO 2max , peak VO 2 , and VAT values will be normalized in a percentage of the predicted VO 2max using reference values for cycle ergometer test in the general paediatric and adult population, as in our previous CPET studies; The clinical outcomes: New York Heart Association (NYHA) functional class, blood pressure, SpO 2 at rest, health care usage (primary and secondary care contacts related to new symptoms and hospitalization), and medication; SV function evaluated by non‐invasive cardiac imaging (echocardiography, magnetic resonance imaging); Biology: NT‐proBNP; The 6 min walk test; Cardiac catheterization: mPAP, TPG, pulmonary capillary wedge pressure, pulmonary artery oxygen saturation, Ao‐Sat, cardiac index, PVRi, SVRi. ; The health‐related quality of life score, using the SF36 questionnaire; The safety outcomes; The acceptability of the intervention to participants.…”

“…This strategy improves survival of children born with an SV. Nevertheless, exercise capacity of these patients remains significantly impaired, and we recently showed that children with a Fontan circulation had a maximum oxygen uptake lowered by 30% compared with healthy matched subjects . Furthermore, long‐term evolution is inexorably marked by a failure of the Fontan circulation, and non‐pulsatile pulmonary blood flow has been associated with the development of pulmonary vascular disease .…”

Impact of a Transition Education Program on the Quality of Life in Pediatric Patients with Congenital Heart Disease: Study Design for a Randomised Controlled Trial

“…As detailed in our previous trials involving exercise capacity assessment, CPET procedures in all participating laboratories will be harmonized. [14,15,24] The level of physical activity with the Ricci and Gagnon questionnaire, composed by 8 items (total score <16 points: no activity; 17 to 32 points: moderate activity; 33 to 40 points: intensive activity). [25] The level of knowledge with the Leuven knowledge questionnaire for CHD.…”