Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease (CAR-DIFF)

University Hospital Center (CHU)

Status: Completed

Conditions: Pulmonary Failure; Systemic Right Ventricle; Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass; Complex Congenital Heart Disease

Treatments: Other: Double pulmonary diffusing

Study type: Interventional

Funder types: Other

Identifiers

NCT02561975

9375

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Patient suffering from complex congenital heart disease

Experimental group

Treatment:

Other: Double pulmonary diffusing