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

NCT02561975 | Completed

• 1 other identifier: 9375
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Membrane ductance (Dm) correlated with VO2max

  membrane ductance (Dm) is assessed by double pulmonary diffusing at rest

  at the time of evaluation at rest (15 minutes before exercise)

Secondary Outcomes (10)

• 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

• 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 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 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 pulmonary diffusing at rest correlated with VO2max

  at the time of evaluation at rest (15 minutes before exercise)

Study Arms (1)

Patient suffering from complex congenital heart disease

EXPERIMENTAL

Other: Double pulmonary diffusing

Interventions

Double pulmonary diffusing 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

Patient suffering from complex congenital heart disease

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic or acute intercurrent respiratory disease
• Participation to another study
• Patient doesn't benefit from an insurance disease regimen
• Pregnant woman or breast-feeding, law-protected person, vulnerable person

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

Study Officials

• Stephan MATECKI, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: September 29, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

FR (1)