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

Not yet recruiting

• Conditions: Pulmonary Hypertension Due to Chronic; Obstructive Pulmonary Disease; Circulating Microvesicles; Circulating Markers of Endothelium Damage

• Registration Number: NCT05250128
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-22
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22
• Study Start: 2022-09
• Primary Completion: 2022-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the rate of circulating endothelial microparticles (EPPs) according to the severity of pulmonary hypertension associated with COPD.	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if hemodynamic control is required (RHC)	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.

Secondary Outcome Measures

Name	Time	Method
Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease	- During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)	Cell stimulation estimated with circulating microvesicles will be dosed.

Trial Locations

Locations (1)

Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France; 🇫🇷 Strasbourg, France