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Completed

NCT Number: NCT02561975

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

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.

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Key information

Conditions

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

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: CAR-DIFF

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 29, 2015
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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