Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease

NCT ID: NCT02561975

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient suffering from complex congenital heart disease

Group Type: EXPERIMENTAL

Double pulmonary diffusing

Intervention Type: OTHER

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

Interventions

Double pulmonary diffusing

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan MATECKI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHU Montpellier

Montpellier, , France

Countries

France

Other Identifiers

9375

Identifier Type: -

Identifier Source: org_study_id