Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease (CAR-DIFF)
Primary Purpose
Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Double pulmonary diffusing
Sponsored by
About this trial
This is an interventional other trial for Complex Congenital Heart Disease focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient suffering from complex congenital heart disease
Arm Description
Outcomes
Primary Outcome Measures
Membrane ductance (Dm) correlated with VO2max
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT02561975
First Posted
January 12, 2015
Last Updated
February 6, 2018
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02561975
Brief Title
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
Acronym
CAR-DIFF
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient suffering from complex congenital heart disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Double pulmonary diffusing
Intervention Description
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
Primary Outcome Measure Information:
Title
Membrane ductance (Dm) correlated with VO2max
Description
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
Time Frame
at the time of evaluation at rest (15 minutes before exercise)
Secondary Outcome Measure Information:
Title
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)
Description
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
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with electrocardiographic parameters
Description
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
Time Frame
at the time of evaluation at rest (15 minutes before exercise)
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
Description
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
Time Frame
3 minutes after the end of a maximal exercise
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
Description
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
Time Frame
10 minutes after the end of a maximal exercise
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max
Description
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
Time Frame
at the time of evaluation at rest (15 minutes before exercise)
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)
Description
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
Time Frame
at the time of evaluation at rest (15 minutes before exercise)
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with VO2max
Description
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
Time Frame
3 minutes after the end of a maximal exercise
Title
diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Description
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
Time Frame
3 minutes after the end of a maximal exercise
Title
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with VO2max
Description
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
Time Frame
10 minutes after the end of a maximal exercise
Title
diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Description
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
Time Frame
10 minutes after the end of a maximal exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan MATECKI, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
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