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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Univentricular Heart Children, Adult Procedure: polysomnography Not Applicable

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.

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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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Johan MOREAU, MD 0467336632 j-moreau@chu-montpellier.fr
Contact: Pascal AMEDRO 0467336632 p-amedro@chu-montpellier.fr

Locations
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France
Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C Recruiting
Montpellier, Occitanie, France, 34295
Contact: Johan Moreau, MD    0467336632    j-moreau@chu-montpellier.fr   
Contact: Pascal Amedro, MD/PhD    0467336632    p-amedro@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03818373     History of Changes
Other Study ID Numbers: RECHMPL17_0400 UF 7512
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Univentricular congenital heart
Sleep apnea
Polysomnography
Respiratory drive
VE/VCO2 slope

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities