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?

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.

Study Overview

• Status: Completed
• Conditions: Univentricular Heart; Children, Adult
• Intervention / Treatment: Procedure: polysomnography

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Palavas-les-Flots, France
    • Institut Saint-Pierre
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with univentricular congenital heart disease; Patients 8 years old or more with functionally univentricular congenital heart disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Johan MOREAU, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Polysomnography; Sleep apnea; VE/VCO2 slope; Univentricular congenital heart; Respiratory drive
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: RECHMPL17_0400; UF 7512 (Other Identifier: Montpellier University hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No