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

NCT ID: NCT05250128

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne RIOU

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Marianne RIOU

Role: CONTACT

+33 369551145

Facility Contacts

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Marianne RIOU

Role: primary

+ 33 369551145

Other Identifiers

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8073

Identifier Type: -

Identifier Source: org_study_id

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