Cardiovascular Comorbidities and Bronchiectasis

NCT02804971 | Completed

• 1 other identifier: BRONCOCA
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Frequency of the cardiovascular comorbidities

  Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.

Secondary Outcomes (3)

• 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.

  Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.

• Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities.

  Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.

• Correlation between biological markers of aging and inflammation.

  Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of bronchiectasis based on imaging in a recent (less than 2 years) CT-scan.

You may qualify if:

• ≤ Age ≤ 80 years
• Formal diagnosis of bronchiectasis by imaging (CT-scan)
• For women, pregnancy test negative
• Affiliation to a social Security
• written inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Chi Creteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Bernard MAITRE

  CHI Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: October 25, 2016
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)