Respiratory Drive in Patients With Univentricular Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT03818373|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Univentricular Heart Children, Adult||Procedure: polysomnography||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||all participants receive the same intervention throughout the protocol|
|Masking:||None (Open Label)|
|Official Title:||Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?|
|Actual Study Start Date :||August 23, 2018|
|Estimated Primary Completion Date :||November 23, 2020|
|Estimated Study Completion Date :||May 23, 2021|
Patients with univentricular congenital heart disease
Patients 8 years old or more with functionally univentricular congenital heart disease
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.
- Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest [ Time Frame: 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
- Pearson correlation [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818373
|Contact: Johan MOREAU, MDemail@example.com|
|Contact: Pascal AMEDROfirstname.lastname@example.org|
|Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C||Recruiting|
|Montpellier, Occitanie, France, 34295|
|Contact: Johan Moreau, MD 0467336632 email@example.com|
|Contact: Pascal Amedro, MD/PhD 0467336632 firstname.lastname@example.org|