NCT03818373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2021

Enrollment Period

3.7 years

First QC Date

January 24, 2019

Last Update Submit

January 2, 2023

Conditions

Univentricular HeartChildren, Adult

Keywords

Univentricular congenital heartSleep apneaPolysomnographyRespiratory driveVE/VCO2 slope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pearson correlation

    day 90 after inclusion visit (visit 2)

Study Arms (1)

Patients with univentricular congenital heart disease

OTHER

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

Procedure: polysomnography

Interventions

polysomnographyPROCEDURE

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.

Patients with univentricular congenital heart disease

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Montpellier, Occitanie, 34295, France

Location

Institut Saint-Pierre

Palavas-les-Flots, France

Location

MeSH Terms

Conditions

Univentricular HeartSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Johan MOREAU

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: all participants receive the same intervention throughout the protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

October 16, 2017

Primary Completion

July 7, 2021

Study Completion

July 7, 2021

Last Updated

January 4, 2023

Record last verified: 2021-12

Locations

FR(2)