Clinical trial NCT05250128: The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Official title: Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Hypertension Due to Chronic
Obstructive Pulmonary Disease
Circulating Microvesicles
Circulating Markers of Endothelium Damage
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Study the rate of circulating endothelial microparticles (EPPs) according to the severity of pulmonary hypertension associated with COPD.
timeFrame: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if hemodynamic control is required (RHC)
Secondary outcomes:
measure: Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease
timeFrame: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
measure: Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease
timeFrame: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
measure: Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease
timeFrame: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Marianne RIOU
role: PRINCIPAL_INVESTIGATOR
References: