Respiratory Drive in Patients With Univentricular Congenital Heart Disease

Univentricular Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818373
• Other study ID #: RECHMPL17_0400
• Secondary ID: UF 7512
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: July 7, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Children, Adult
• Heart Defects, Congenital
• Heart Diseases
• Univentricular Heart

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C	Montpellier	Occitanie
France	Institut Saint-Pierre	Palavas-les-Flots

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)