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Respiratory Drive in Patients With Univentricular Congenital Heart Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03818373
Enrollment
32
Registered
2019-01-28
Start date
2017-10-16
Completion date
2021-07-07
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Adult, Univentricular Heart

Keywords

Univentricular congenital heart, Sleep apnea, Polysomnography, Respiratory drive, VE/VCO2 slope

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.

Interventions

PROCEDUREpolysomnography

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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

all participants receive the same intervention throughout the protocol

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at restday 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

Secondary

MeasureTime frameDescription
Pearson correlationday 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026