NCT05783869

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2023Nov 2026

First Submitted

Initial submission to the registry

February 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

February 12, 2023

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Hospitalization frequency in patient group compared to control group.

    March 2023 to September 2023

Study Arms (2)

Patient with bronchiectasis and cardiovascular comorbidities

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

Device: Echocardiography

Patients with bronchiectasis and without cardiovascular comorbidities

Patients with Bronchiectasis had no comorbidities.

Device: Echocardiography

Interventions

echocardiographic study of both groups

Also known as: Pulmonary function test, Routine laboratory investigations and inflammatory markers
Patient with bronchiectasis and cardiovascular comorbiditiesPatients with bronchiectasis and without cardiovascular comorbidities

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients at the study period attending the chest department at Assuit university

You may qualify if:

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

You may not qualify if:

  • Any Patients who refuse to participate in the study.
  • Any other comorbidity or end-organ failure may affect the study's result.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut unviresty - Faculty of Medicine

Asyut, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

EchocardiographyRespiratory Function Tests

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques, Respiratory System

Study Officials

  • Ahmad Shaddad

    Assuit University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Ahmad Shaddad

    Assiut University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaadad Shaddad, MD

CONTACT

Ahmad Shaddad, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pulmonary medicine Assuit university

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 24, 2023

Study Start

March 25, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations