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Clinical Trials/NCT03818373
NCT03818373
Completed
Not Applicable

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

University Hospital, Montpellier2 sites in 1 country32 target enrollmentOctober 16, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Univentricular Heart
Sponsor
University Hospital, Montpellier
Enrollment
32
Locations
2
Primary Endpoint
Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2017
End Date
July 7, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Pearson correlation(day 90 after inclusion visit (visit 2))

Study Sites (2)

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