Complex Congenital Heart DiseaseCAR-DIFFNCT02561975
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
A study testing Double pulmonary diffusing in people with Complex Congenital Heart Disease and Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, run by University Hospital, Montpellier at 1 site in France.
Trial summary
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle
- What is being tested?
- Double pulmonary diffusing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2017
- 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
- Informed consent
- Age > 8 years- female and male patients
- Heart-rate exercise tolerance test planned in the usual patient's follow-up
- Congenital heart disease: single ventricle with Fontan circulation or bicavo-bipulmonary bypass or systemic right ventricle or pulmonary failure
Who cannot join
- Chronic or acute intercurrent respiratory disease
- In exclusion period in relation with another trial or for
- Participation to another study
- Patient doesn't benefit from an insurance disease regimen
- Pregnant woman or breast-feeding, law-protected person, vulnerable person
Trial locations and contacts
1 site in 1 country.
About this study
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.
There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.
Read more
The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).
Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.
Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.
The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.
- Conditions
- Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle, Pulmonary Failure
- Being tested
- Double pulmonary diffusing
- Keywords
- Double pulmonary diffusing capacity to carbon monoxyd (CO) associated to nitric oxide (NO), Evolution of membrane and capillar damages, Early pronostic value of congenital heart disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double pulmonary diffusingOther
Measure of double pulmonary diffusing will be done as the single-breath test: the patient will be seated and connected to device by an oral tip. Measure begins by a maximal inhalation of a gas mixture (0.28% of CO, 14% of He, 21% of O2,450 ppm of NO/N2 and 40ppm of NO).After, the patient will maintain an apnea of 4 secondes and will breathe out in oral tip until his residual capacity.
With the expired air, some parameters will be assessed:
- Alveolar volume (VA)
- Membrane ductance (Dm) and pulmonar capillary volume (values adjusted by Haemoglobin)
- Values of TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
| Study group | Role | What they receive |
|---|---|---|
| Patient suffering from complex congenital heart disease | Experimental | Not described Receives: Other: Double pulmonary diffusing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Membrane ductance (Dm) correlated with VO2max
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
Measured: at the time of evaluation at rest (15 minutes before exercise)
Secondary outcomes (10)
capillary pulmonary recruitment during exercise correlated with VO2max. (capillary pulmonary volume 3 minutes after the end of a maximal exercise minus capillary pulmonary volume at rest)
capillary pulmonary volume 3 minutes after the end of a maximal exercise minus capillary pulmonary volume at rest
Measured: at the time of evaluation at rest (15 minutes before exercise) and 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with electrocardiographic parameters
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO and Dm/Vc
Measured: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 10 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO and Dm/Vc
Measured: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO and Dm/Vc
Measured: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with VO2max
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 3 minutes after the end of a maximal exercise
diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with VO2max
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 10 minutes after the end of a maximal exercise
diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
parameters assessed during measure TLCO/TLNO of double diffusing are TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc
Measured: 10 minutes after the end of a maximal exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan MATECKI, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561975
- Sponsor's protocol ID
- 9375
- Acronym
- CAR-DIFF
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2015
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02561975
- Acronym / sponsor ID
- CAR-DIFF / 9375
- Conditions
- Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle, Pulmonary Failure
- Keywords
- Double pulmonary diffusing capacity to carbon monoxyd (CO) associated to nitric oxide (NO), Evolution of membrane and capillar damages, Early pronostic value of congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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.
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.
There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.
The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).
Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.
Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.
The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient suffering from complex congenital heart disease | Experimental | Other: Double pulmonary diffusing |
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)
- Informed consent
- Age > 8 years- female and male patients
- Heart-rate exercise tolerance test planned in the usual patient's follow-up
- Congenital heart disease: single ventricle with Fontan circulation or bicavo-bipulmonary bypass or systemic right ventricle or pulmonary failure
Key exclusion criteria (5 listed)
- Chronic or acute intercurrent respiratory disease
- In exclusion period in relation with another trial or for
- Participation to another study
- Patient doesn't benefit from an insurance disease regimen
- Pregnant woman or breast-feeding, law-protected person, vulnerable person
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 |
|---|---|---|
| Double pulmonary diffusingMeasure of double pulmonary diffusing will be done as the single-breath test: the patient will be seated and connected to device by an oral tip. Measure begins by a maximal inhalation of a gas mixture (0.28% of CO, 14% of He, 21% of O2,450 ppm of NO/N2 and 40ppm of NO).After, the patient will maintain an apnea of 4 secondes and will breathe out in oral tip until his residual capacity. With the expired air, some parameters will be assessed: * Alveolar volume (VA) * Membrane ductance (Dm) and pulmonar capillary volume (values adjusted by Haemoglobin) * Values of TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc | Other | Patient suffering from complex congenital heart disease |
Primary outcome
Membrane ductance (Dm) correlated with VO2max
Time frame: at the time of evaluation at rest (15 minutes before exercise)
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
10 secondary outcomes
capillary pulmonary recruitment during exercise correlated with VO2max. (capillary pulmonary volume 3 minutes after the end of a maximal exercise minus capillary pulmonary volume at rest)
Time frame: at the time of evaluation at rest (15 minutes before exercise) and 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with electrocardiographic parameters
Time frame: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
Time frame: 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
Time frame: 10 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max
Time frame: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)
Time frame: at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with VO2max
Time frame: 3 minutes after the end of a maximal exercise
diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Time frame: 3 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with VO2max
Time frame: 10 minutes after the end of a maximal exercise
diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Time frame: 10 minutes after the end of a maximal exercise
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 7 Feb 2018.
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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.
Stephan MATECKI, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double pulmonary diffusing in people with Complex Congenital Heart Disease and Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, run by University Hospital, Montpellier at 1 site 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 5 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Membrane ductance (Dm) correlated with VO2max (time frame: at the time of evaluation at rest (15 minutes before exercise)). 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 7 Feb 2018.