Idiopathic Bronchiectasis and Pulmonary Hypertension

• ClinicalTrials.gov Identifier: NCT03883048
• Recruitment Status: Completed
• First Posted: March 20, 2019
• Last Update Posted: February 4, 2022
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Information provided by (Responsible Party): Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Study Description

Brief Summary:

Through analysis of demographic factors (gender, age, smoking history and body mass index), clinical indicators (signs and symptoms), sputum culture results (pseudomonas aeruginosa), brain natriuretic peptide and imaging (scope and type of bronchiectasis), pulmonary function index, inflammatory cytokines and inflammasome of patients, some factors will be found which maybe be related to severity and prognosis of pulmonary hypertension associated with bronchiectasis.

Condition or disease	Intervention/treatment
Bronchiectasis; Pulmonary Hypertension	Other: Observation of bronchiectasis with pulmonary hypertension

Detailed Description:

The patients with bronchiectasis from Jan 2014 to Dec 2019 were retrospectively analyzed. The patients were advised to measure mean pulmonary artery pressure with a right heart catheter, if the pulmonary artery systolic pressure estimated by echocardiography was greater than or equal to 40mmHg, or the pulmonary artery to aorta width ratio was greater than 1. With the consent of the patient, the mean pulmonary artery pressure was measured by right heart catheterization to determine whether the patient had complications pulmonary hypertension.

The patients were diagnosed as bronchiectasis with pulmonary hypertension through right cardiac catheterization, the data of pulmonary artery systolic pressure of echocardiographic estimates, pulmonary artery width and the pulmonary artery and aorta width ratio were analyzed. The relevance, specificity and sensitivity between mean pulmonary artery pressure measured by right heart catheterization and the three indexes were analyzed to determine which indicators can be better evaluate bronchiectasis with noninvasive indicator of pulmonary hypertension.

These patients were divided into bronchiectasis with pulmonary hypertension group and bronchiectasis without pulmonary hypertension group according to the most outstanding noninvasive indicator. Demographic factors (gender, age, smoking history and body mass index), clinical indicators (signs and symptoms), laboratory examination (serum and sputum) and imaging (scope and type of bronchiectasis), pulmonary function index, the number of acute exacerbation in the past year and hospitalization days would be analyzed to explore the factors which contribute pulmonary hypertension in patients with bronchiectasis. These patients were divided into survival and death groups according to the results of follow-up. Above indexes between the different groups will be analyzed to explore which factors can be independent factors combined with bronchiectasis pulmonary hypertension and the prognosis of patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 1606 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Analysis of Influencing Factor of the Severity and Prognosis of Pulmonary Hypertension Associated With Idiopathic Bronchiectasis.
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Differance of some indexes between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension [ Time Frame: June/01/2018-Decemeber/31/2021 ]
   Differance of some indexes (ie. course, clinical presentation, type of bronchiolitis, lung function and pseudomonas aeruginosa) between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

1.The patients with Bronchiectasis from Jan 2014 to Dec 2019.

Criteria

Inclusion Criteria:

1. Age ≥ 18;
2. Patients with typical bronchiectasis on CHEST HRCT;
3. Patients with bronchiectasis without known cause.

Exclusion Criteria:

1. Patients with allergic bronchopulmonary aspergillosis (ABPA).
2. Patients with bronchiectasis combined with pulmonary tuberculosis and non-tuberculous mycobacterium tuberculosis.
3. Patients with bronchiectasis due to genetic factors.
4. Bronchiectasis patients with connective tissue diseases.
5. Patients with bronchiectasis with interstitial lung disease.
6. Combined with pulmonary embolism, pneumothorax, mediastinal emphysema and lung tumor.
7. Patients with bronchiectasis associated with chronic obstructive pulmonary and bronchial asthma.
8. Patients with severe heart, brain, liver and renal dysfunction.

Contacts and Locations

Locations

China, Shanghai

Shanghai Pulmonary Hospital, Tongji University

Shanghai, Shanghai, China, 200000

Sponsors and Collaborators

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

• Study Director: Jin-fu Mr Xu, Doctor; Shanghai Pulmonary Hospital, Shanghai, China

More Information

• Responsible Party: Jin-Fu Xu, Proffessor, Shanghai Pulmonary Hospital, Shanghai, China
• ClinicalTrials.gov Identifier: NCT03883048
• Other Study ID Numbers: 2018052395
• First Posted: March 20, 2019
• Last Update Posted: February 4, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension, Pulmonary; Bronchiectasis; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases