Respiratory Drive in Patients With Univentricular Congenital Heart Disease

NCT ID: NCT03818373

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2021-07-07

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.

Conditions

Univentricular Heart; Children, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with univentricular congenital heart disease

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

Group Type: OTHER

polysomnography

Intervention Type: PROCEDURE

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.

Interventions

polysomnography

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan MOREAU

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C

Montpellier, Occitanie, France

Institut Saint-Pierre

Palavas-les-Flots, , France

Countries

France

Other Identifiers

UF 7512

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL17_0400

Identifier Type: -

Identifier Source: org_study_id