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Clinical Trials/NCT05250128
NCT05250128
Not yet recruiting
Not Applicable

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

University Hospital, Strasbourg, France1 site in 1 country80 target enrollmentSeptember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension Due to Chronic
Sponsor
University Hospital, Strasbourg, France
Enrollment
80
Locations
1
Primary Endpoint
Study the rate of circulating endothelial microparticles (EPPs) according to the severity of pulmonary hypertension associated with COPD.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
September 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Study the rate of circulating endothelial microparticles (EPPs) according to the severity of pulmonary hypertension associated with COPD.

Time Frame: - 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 Outcomes

  • 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))

Study Sites (1)

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