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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05250128
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Strasbourg, France
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marianne RIOU
Principal Investigator Affiliation	Hôpitaux Universitaires de Strasbourg
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension Due to Chronic, Obstructive Pulmonary Disease, Circulating Microvesicles, Circulating Markers of Endothelium Damage

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