Clinical trial NCT02561975: Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Membrane ductance (Dm) correlated with VO2max
timeFrame: at the time of evaluation at rest (15 minutes before exercise)
Secondary outcomes:
measure: 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)
timeFrame: at the time of evaluation at rest (15 minutes before exercise) and 3 minutes after the end of a maximal exercise
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with electrocardiographic parameters
timeFrame: at the time of evaluation at rest (15 minutes before exercise)
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
timeFrame: 3 minutes after the end of a maximal exercise
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with electrocardiographic parameters
timeFrame: 10 minutes after the end of a maximal exercise
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max
timeFrame: at the time of evaluation at rest (15 minutes before exercise)
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)
timeFrame: at the time of evaluation at rest (15 minutes before exercise)
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 3 minutes after the end of a maximal exercise correlated with VO2max
timeFrame: 3 minutes after the end of a maximal exercise
measure: diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
timeFrame: 3 minutes after the end of a maximal exercise
measure: parameters assessed during measure TLCO/TLNO of double pulmonary diffusing 10 minutes after the end of a maximal exercise correlated with VO2max
timeFrame: 10 minutes after the end of a maximal exercise
measure: diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
timeFrame: 10 minutes after the end of a maximal exercise
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Stephan MATECKI, MD
role: PRINCIPAL_INVESTIGATOR
References: