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Completed

NCT Number: NCT03818373

Respiratory Drive in Patients With 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.

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Key information

Conditions

Univentricular Heart Apnea Cardiovascular Abnormalities Cardiovascular Diseases Children, Adult Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Heart Defects, Congenital Heart Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C, Montpellier, Occitanie, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2019
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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