Univentricular HeartNCT03818373
Respiratory Drive in Patients With Univentricular Congenital Heart Disease
A study testing polysomnography in people with Univentricular Heart and Children, Adult, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Univentricular Heart, Children, Adult
- What is being tested?
- polysomnography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Oct 2017to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C
Montpellier, Occitanie, 34295
Institut Saint-Pierre
Palavas-les-Flots
About this study
Official title: Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a 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.
Read the 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.
- Conditions
- Univentricular Heart, Children, Adult
- Being tested
- polysomnography
- Keywords
- Univentricular congenital heart, Sleep apnea, Polysomnography, Respiratory drive, VE/VCO2 slope
- Medical subject headings
- Univentricular Heart, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with univentricular congenital heart disease | Other | Patients 8 years old or more with functionally univentricular congenital heart disease Receives: Procedure: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 90 after inclusion visit (visit 2)
Secondary outcomes (1)
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
Measured: day 90 after inclusion visit (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start16 Oct 2017
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all participants receive the same intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan MOREAU, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818373
- Sponsor's protocol ID
- RECHMPL17_0400
- Other IDs
- UF 7512
- Status last verified
- Dec 2021
- First submitted
- 24 Jan 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?
- ClinicalTrials.gov ID
- NCT03818373
- Acronym / sponsor ID
- RECHMPL17_0400
- Conditions
- Univentricular Heart, Children, Adult
- Keywords
- Univentricular congenital heart, Sleep apnea, Polysomnography, Respiratory drive, VE/VCO2 slope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all participants receive the same intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Patients with univentricular congenital heart disease | Other | Procedure: polysomnographyPatients 8 years old or more with functionally univentricular congenital heart disease |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnographySleep 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. | Procedure or surgery | Patients with univentricular congenital heart disease |
Primary outcome
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
1 secondary outcome
Pearson correlation
Time frame: day 90 after inclusion visit (visit 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan MOREAU principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Univentricular Heart and Children, Adult, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.