Respiratory Drive in Patients With Univentricular Congenital Heart Disease

University Hospital Center (CHU)

Status: Completed

Conditions: Univentricular Heart; Children, Adult

Treatments: Procedure: polysomnography

Study type: Interventional

Funder types: Other

Identifiers

NCT03818373

RECHMPL17_0400

UF 7512 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Patients with univentricular congenital heart disease

Other group

Description:

Patients 8 years old or more with functionally univentricular congenital heart disease

Treatment:

Procedure: polysomnography