Cardiovascular Comorbidities and Bronchiectasis

Bronchiectasis Clinical Trial

— BRONCOCA  

Official title:

Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02804971
• Other study ID #: BRONCOCA
• Status: Active, not recruiting
• Start date: October 25, 2016
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
France	Chi Creteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of the cardiovascular comorbidities		Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.
Secondary	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.
Secondary	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.
Secondary	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.