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Respiratory Drive in Patients With Univentricular Congenital Heart Disease

Primary Purpose

Univentricular Heart, Children, Adult

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

polysomnography

About this trial

This is an interventional diagnostic trial for Univentricular Heart focused on measuring Univentricular congenital heart, Sleep apnea, Polysomnography, Respiratory drive, VE/VCO2 slope

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C
Institut Saint-Pierre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with univentricular congenital heart disease

Arm Description

Patients 8 years old or more with functionally univentricular congenital heart disease

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03818373

First Posted

January 24, 2019

Last Updated

January 2, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03818373

Brief Title

Respiratory Drive in Patients With Univentricular Congenital Heart Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2017 (Actual)

Primary Completion Date

July 7, 2021 (Actual)

Study Completion Date

July 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Univentricular Heart, Children, Adult

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

all participants receive the same intervention throughout the protocol

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with univentricular congenital heart disease

Arm Type

Other

Arm Description

Patients 8 years old or more with functionally univentricular congenital heart disease

Intervention Type

Procedure

Intervention Name(s)

polysomnography

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

day 90 after inclusion visit (visit 2)

Secondary Outcome Measure Information:

Title

Pearson correlation

Description

Time Frame

day 90 after inclusion visit (visit 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johan MOREAU

Organizational Affiliation

Montpellier University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C

City

Montpellier

State/Province

Occitanie

ZIP/Postal Code

34295

Country

France

Facility Name

Institut Saint-Pierre

City

Palavas-les-Flots

Country

France

12. IPD Sharing Statement

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Respiratory Drive in Patients With Univentricular Congenital Heart Disease

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