Cardiovascular Comorbidities and Bronchiectasis

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Brief Title

Cardiovascular Comorbidities and Bronchiectasis

Official Title

Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Brief Summary

      Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with
      inflammation, which leads to a progressive lung deterioration. This disease is responsible
      for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of
      hospitalization. Natural history is marked by recurrent infectious diseases which are the
      main prognosis factor. This disease is associated with an inflammation rate in the lung as
      well as in the blood. Up to now, no study has been described comorbidities associated with
      this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent
      in these patients. In fact systemic inflammation driven by bronchial infections may increase
      frequency of cardiovascular diseases.

      The investigators decide to conduct a monocentric observational study to define the
      prevalence and characterization of cardiovascular comorbidities as well as markers of
      accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are
      frequent in bronchiectasis and may be associated with markers of inflammation and aging.

      Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement
      according to the ATS/ERS guideline. 6M walking test and echocardiography will be also
      performed.

      Frequency of comorbidities will be calculated with data from questionnaire as well as
      standardized explorations.

      Aging related manifestations will be measured: arterial stiffness using aortic pulse wave
      velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal
      muscle mass and grip test were also performed.

      Blood test were also performed to measure inflammatory markers, cytokines and length of
      telomere in circulating leucocytes.
    

Detailed Description

      Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement
      according to the ATS/ERS guideline. 6M walking test and echocardiography will be also
      performed.

      Frequency of comorbidities will be calculated with data from questionnaire as well as
      standardized explorations.

      Aging related manifestations will be measured: arterial stiffness using aortic pulse wave
      velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal
      muscle mass and grip test were also performed.

      Blood test were also performed to measure inflammatory markers, cytokines and length of
      telomere in circulating leucocytes.
    


Study Type

Observational


Primary Outcome

Frequency of the cardiovascular comorbidities

Secondary Outcome

 Frequency of aging-related abnormalities (higher aortic pulse-wave velocity, lower bone mineral density, lower squelettal muscle mass index) and shorter telomere length in patients.

Condition

Bronchiectasis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

September 2016

Completion Date

December 2022

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          -  40 ≤ Age ≤ 80 years

          -  Formal diagnosis of bronchiectasis by imaging (CT-scan)

          -  For women, pregnancy test negative

          -  Affiliation to a social Security

          -  written inform consent

        Exclusion Criteria:

          -  Patients with a diagnosis of Cystic Fibrosis

          -  Contre indication of one of the tests

          -  Exacerbation with hospitalization or outpatient clinic visit in the last 4 weeks.

          -  Unability to obtain an informed consent

          -  Pregnancy or Breast feeding
      

Gender

All

Ages

40 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Bernard MAITRE, 1 57 02 21 17, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02804971

Organization ID

BRONCOCA


Responsible Party

Principal Investigator

Study Sponsor

Centre Hospitalier Intercommunal Creteil


Study Sponsor

Bernard MAITRE, Principal Investigator, CHI Créteil


Verification Date

July 2020