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OpenTrials
Completed

NCT Number: NCT02804971

Cardiovascular Comorbidities and Bronchiectasis

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chi Creteil

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of the cardiovascular comorbidities

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

Secondary outcomes

  1. 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.

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

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

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

  3. Correlation between biological markers of aging and inflammation.

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Acronym: BRONCOCA

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2016
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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