Respiratory Drive in Patients With Univentricular Congenital Heart Disease

Study Overview
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Brief Summary
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The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing. The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.

Detailed Description
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The patients with univentricular congenital heart disease will perform : a cardiopulmonary exercise testing with measure VE/VCO2 slope, a measure of the respiratory drive to hypercapnia with occlusion pressure during the rebreathing with at rest (P0,1/PetCO2). A polysomnography with a scoring of central apnea index. Correlation will be evaluate between P 0,1/PetCO2 with VE/VCO2 slope and between P0,1/PetCO2 central apnea index.

Official Title
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Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?

Conditions
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Univentricular Heart, Children, Adult

Intervention / Treatment
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* Procedure: polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Functionally univentricular congenital heart disease Age ≥ 8 years Consent of the adult patient or the parents or legal guardians of the minor patient. Beneficiary of the social security scheme Exclusion Criteria: Size <120 cm (minimum size for the stress test) Medical contraindication to exercise test or presence of : myocardial infarction less than 3 months old, unstable angina, uncontrolled severe arrhythmias, symptomatic aortic stenosis, uncontrolled heart failure, pulmonary embolism, evolutionary phlebitis, pericarditis, myocarditis, progressive endocarditis, aortic dissection Unstable patient with severe intellectual disability or complex pathology making polysomnography impossible Pregnant woman

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: all participants receive the same intervention throughout the protocol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with univentricular congenital heart disease<br>Patients 8 years old or more with functionally univentricular congenital heart disease | Procedure: polysomnography<br>* Sleep examination strictly non-invasive with skin sensors. This exploration would allow for the detection of respiratory sleep disorders and consider of appropriate management for patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest | between the measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest - between VE/VCO2 slope during a cardiopulmonary exercise | day 90 after inclusion visit (visit 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson correlation | between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and Central apnea index scored with a polysomnography during a night between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and NYHA, New York Heart Association Functional Classification between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and the quality of life evaluated by questionary between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and data of cardiac echography | day 90 after inclusion visit (visit 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Univentricular congenital heart, Sleep apnea, Polysomnography, Respiratory drive, VE/VCO2 slope