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

February 6, 2018 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient suffering from complex congenital heart disease
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Membrane ductance (Dm) correlated with VO2max
Time Frame: at the time of evaluation at rest (15 minutes before exercise)
membrane ductance (Dm) is assessed by double pulmonary diffusing at rest
at the time of evaluation at rest (15 minutes before exercise)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
10 minutes after the end of a maximal exercise
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with VO2max
Time Frame: 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
at the time of evaluation at rest (15 minutes before exercise)
parameters assessed during measure TLCO/TLNO of double pulmonary diffusing at rest correlated with clinic dyspnea (NYHA)
Time Frame: 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
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 VO2max
Time Frame: 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
3 minutes after the end of a maximal exercise
diffusing 3 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Time Frame: 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
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 VO2max
Time Frame: 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
10 minutes after the end of a maximal exercise
diffusing 10 minutes after the end of a maximal exercise correlated with clinic dyspnea (NYHA)
Time Frame: 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
10 minutes after the end of a maximal exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Stephan MATECKI, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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