Idiopathic Bronchiectasis and Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

The Optimal Noninvasive Indicator for Identify Pulmonary Hypertension Will be Determined. Difference of Some Indexes Between Bronchiectasis With Pulmonary Hypertension and Bronchiectasis Without Pulmonary Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883048
• Other study ID #: 2018052395
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with idiopathic bronchiectasis who received right heart catheterization (RHC) were included to evaluate the consistency between pulmonary arterial pressure (PAP) and other noninvasive indicators (pulmonary arterial systolic pressure [PASP] calculated by echocardiography, main pulmonary artery [MPA] diameter and MPA/ascending aorta ratio on chest high-resolution computed tomography [HRCT]). Then the optimal noninvasive indicator for identify PH was determined and its critical point was obtained according to the Youden Index. Based on this, we investigate the proportion, risk factors and prognosis of PH in idiopathic bronchiectasis patients in another large-scale population.

Description:

Between April 2011 and December 2019, the data of idiopathic bronchiectasis patients were analyzed to determine the optimal noninvasive tool to identify PH. Based on the patients who received RHC examination, Spearman correlation was used to assess the correlation between mean pulmonary arterial pressure (mPAP) and systolic pulmonary arterial pressure (sPAP) measured by RHC and other noninvasive indicators (estimated PASP assessed by echocardiography, main pulmonary artery (MPA) diameter and MPA/ ascending aorta (AA) ratio on chest HRCT scan), in order to screening out the optimal indicator to identify PH. Then the sensitivity and specificity of the indicator was calculated through the receiving operating characteristics (ROC) analysis and the critical point of the indicator was determined by Youden index.

Based on critical point of that indicator, a large sample study from hospital medical database for patients with idiopathic bronchiectasis in Shanghai Pulmonary Hospital (Shanghai, China) between May 2013 and December 2019 was conducted. The following data were collected: demographic information (i.e., age and sex); clinical characteristics (age of symptom onset, duration after bronchiectasis diagnosis, and body mass index [BMI]); radiological presentation (the type of bronchiectasis, and involved lung lobe and segment); pulmonary function (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], and FEV1/FVC); N-terminal pro brain natriuretic peptide (N-proBNP); arterial blood gas and microbiological detection in respiratory tract specimen (sputum or bronchoalveolar lavage fluid). The number of hospitalizations and emergency visits in past 12 months before the first hospitalization were collected based on patient's medical records. Patients were followed up by telephone until December 2021.

The idiopathic patients who received echocardiography examination were divided into two groups. The risk factors of PH associated with idiopathic bronchiectasis and the effect of PH on the prognosis of patients with bronchiectasis were analyzed through statistical method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1606
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• Observation of bronchiectasis with pulmonary hypertension

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital, Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The optimal noninvasive indicator for identify pulmonary hypertension	Based on the patients who received right heart catheterization examination, the optimal noninvasive indicator for identify PH was determined	April/01/2011-Decemeber/31/2019
Primary	Differance of some indexes between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension	Differance of some indexes (ie. course, clinical presentation, type and scope of bronchiolitis, lung function, pseudomonas aeruginosa in respiratory tract specimen and prognosis) between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension	May/01/2013-Decemeber/31/2019