Clinical trial NCT02804971: Cardiovascular Comorbidities and Bronchiectasis
Official title: Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of bronchiectasis based on imaging in a recent (less than 2 years) CT-scan.

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.

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

Primary outcomes:
measure: Frequency of the cardiovascular comorbidities
timeFrame: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.
Secondary outcomes:
measure: 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.
timeFrame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
measure: Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities.
timeFrame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
measure: Correlation between biological markers of aging and inflammation.
timeFrame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Chi Creteil
Study officials:
affiliation: CHI Créteil
name: Bernard MAITRE
role: PRINCIPAL_INVESTIGATOR
References: