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