Study of Bronchiectasis and Associated Cardiovascular Comorbidities

Bronchiectasis Clinical Trial

Official title:

Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783869
• Other study ID #: 23455668
• Status: Recruiting
• Start date: March 25, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Shaadad Shaddad, MD
• Phone: +201111171930
• Email: shaddad_ahmad[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis

Description:

The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.

Exclusion Criteria:

• Any Patients who refuse to participate in the study.

• Any other comorbidity or end-organ failure may affect the study's result.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Device:
• Echocardiography
echocardiographic study of both groups

Locations

Country	Name	City	State
Egypt	Assiut unviresty - Faculty of Medicine	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Aliae AR Mohamed Hussein [ahussein

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.	Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.	March 2023 to September 2023
Primary	Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)	The Short Form (36) Health Survey will be performed in both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	March 2023 to September 2023
Secondary	Hospitalization frequency in patient group compared to control group.	Number of hospital admission in the last year will be compared in both groups.	March 2023 to September 2023