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Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis (DL-SSc)

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ClinicalTrials.gov Identifier: NCT03601520
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Description
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Brief Summary:
This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).

Condition or disease
Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis

Detailed Description:
In systemic sclerosis (SSc) the impairment of lung function is generally inferred from measurements of forced vital capacity (FVC) and standard lung diffusing capacity for carbon monoxide (DLCO). However, FVC measurement does not provide an accurate estimate of lung restriction and DLCO does not allow separate the alveolar membrane (DMCO) from erythrocyte (DeCO) diffusive conductance for CO. Previous studies have shown that DMCO and DeCO may change irrespective of overt intersitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). These changes may be consistent with a limitation of alveolar-capillary erythrocyte recruitment which impairs DM.This study was designed to test the hypothesis that, irrespective of the degree of ILD and/or PAH, combined DLNO-DLCO measurement might be useful to provide a mechanistic interpretation of DM and De changes in SSc.
Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Lung diffusing capacity for nitric oxide [ Time Frame: 2 hours ]
    Alveolar-capillary gas exchange


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
SSc patients
Criteria

Inclusion Criteria:

  • patients fulfilling the 2013 American College of Rheumatology/European League Against Rheumatism criteria for a definite diagnosis of SSc with a total score ≥9

Exclusion Criteria:

  • unstable subjects and/or who have suffered from respiratory exacerbations in the previous 4-wk
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Giovanni Barisione, MD, Pulmonary Function Lab Director, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT03601520    
Other Study ID Numbers: IRCCS-SSc-2018
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Connective Tissue Diseases
Skin Diseases