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?
Verified date | December 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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) |
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