The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Obstructive Pulmonary Disease Clinical Trial

— MICROBOPH  

Official title:

Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05250128
• Other study ID #: 8073
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: September 2025

Study information

• Verified date: February 2022
• Source: University Hospital, Strasbourg, France
• Contact: Marianne RIOU
• Phone: +33 369551145
• Email: marianne.riou[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex.

For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed.

We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age = 18

• COPD: obstructive ventilatory insufficient on spirometry and history of smoking

• patients who will perform right heart catheterization

• Signature of written informed consent

Exclusion criteria:

• LVEF < 45% (echocardiography)

• Post-capillary pulmonary hypertension (pulmonary capillary wedge pressure > 15 mmHg)

• Chronic Thromboembolic hypertension

• Pulmonary embolism < 6 months

• Acute coronary syndrome < 3 months

• Significant cardiac valvulopathy (echocardiography)

• Portal hypertension

• Connective tissue disease

• chronic renal insufficient (clearance < 40 ml/min)

• Glycated hemoglobin > 7% (if diabetes)

• Non controlled arterial hypertension

• Positive beta-HCG

• Respiratory exacerbation during the inclusive period

• Patients under guardianship or curatorship

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Catheterization
Right heart catheterization, using the Swan-Ganz standard technique, to measure mean pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and pulmonary vascular resistance

Locations

Country	Name	City	State
France	Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the rate of circulating endothelial microparticles (EPPs) according to the severity of pulmonary hypertension associated with COPD.	Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from COPD patients who have hemodynamic assessment by RHC. Samples will be withdrawn from occluded pulmonary artery and jugular vein during the exam.	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if hemodynamic control is required (RHC)
Secondary	Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease	Circulating markers of endothelium damage with circulating microvesicles will be dosed.	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
Secondary	Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease	Proinflammatory markers with circulating microvesicles will be dosed.	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
Secondary	Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease	Cell stimulation estimated with circulating microvesicles will be dosed.	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)