Respiratory Drive in Patients With Univentricular Congenital Heart Disease

Not Applicable

Completed

• Conditions: Univentricular Heart; Children, Adult
• Interventions: Procedure: polysomnography

• Registration Number: NCT03818373
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2021-12
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with univentricular congenital heart disease	polysomnography	Patients 8 years old or more with functionally univentricular congenital heart disease

Primary Outcome Measures

Name	Time	Method
Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest	day 90 after inclusion visit (visit 2)	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

Secondary Outcome Measures

Name	Time	Method
Pearson correlation	day 90 after inclusion visit (visit 2)	* 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

Trial Locations

Locations (2)

Institut Saint-Pierre; 🇫🇷 Palavas-les-Flots, France

Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C; 🇫🇷 Montpellier, Occitanie, France