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

Not Applicable

Completed

• Conditions: Systemic Right Ventricle; Complex Congenital Heart Disease; Pulmonary Failure; Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass
• Interventions: Other: Double pulmonary diffusing

• Registration Number: NCT02561975
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-29
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient suffering from complex congenital heart disease	Double pulmonary diffusing	-

Primary Outcome Measures

Name	Time	Method
Membrane ductance (Dm) correlated with VO2max	at the time of evaluation at rest (15 minutes before exercise)	membrane ductance (Dm) is assessed by double pulmonary diffusing at rest

Secondary Outcome Measures

Name	Time	Method
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)	at the time of evaluation at rest (15 minutes before exercise) and 3 minutes after the end of a maximal exercise	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	at the time of evaluation at rest (15 minutes before exercise)	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	3 minutes after the end of a maximal exercise	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	10 minutes after the end of a maximal exercise	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	at the time of evaluation at rest (15 minutes before exercise)	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)	at the time of evaluation at rest (15 minutes before exercise)	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	3 minutes after the end of a maximal exercise	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)	3 minutes after the end of a maximal exercise	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	10 minutes after the end of a maximal exercise	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)	10 minutes after the end of a maximal exercise	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

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France