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

NCT05250128 | Unknown

• 1 other identifier: 8073
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Samples will be withdrawn from occluded pulmonary artery and jugular vein during the exam.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 Outcomes (3)

• 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)

• 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)

• 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)

Interventions

Catheterization PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease, addressed to the competence center PulmoTension of the Strasbourg University hospital, France: * who are considered for lung transplantation; * with severe hypoxemia; * with suspicion of pulmonary hypertension (on echocardiography) And who perform right heart catheterization.

You may qualify if:

• Age ≥ 18
• COPD: obstructive ventilatory insufficient on spirometry and history of smoking
• patients who will perform right heart catheterization
• Signature of written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

During right-heart catheterization, blood samples are collected from the occluded pulmonary artery and the jugular vein. Platelet-poor plasma (PPP) samples are obtained by double centrifugation.

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Marianne RIOU

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne RIOU

CONTACT

+33 369551145; marianne.riou@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 22, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2025
• Last Updated: June 22, 2022

Record last verified: 2022-02

Locations

FR (1)