Clinical trial NCT03818373: Respiratory Drive in Patients With Univentricular Congenital Heart Disease
Official title: Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Univentricular Heart
Children, Adult
Keywords: Univentricular congenital heart
Sleep apnea
Polysomnography
Respiratory drive
VE/VCO2 slope
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants receive the same intervention throughout the protocol
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
timeFrame: day 90 after inclusion visit (visit 2)
Secondary outcomes:
measure: Pearson correlation
timeFrame: day 90 after inclusion visit (visit 2)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C
state: Occitanie
city: Palavas-les-Flots
country: France
facility: Institut Saint-Pierre
Study officials:
affiliation: Montpellier University Hospital
name: Johan MOREAU
role: PRINCIPAL_INVESTIGATOR
References: