Pulmonary Hypertension Due to ChronicMICROBOPHNCT05250128
The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Hypertension Due to Chronic and Obstructive Pulmonary Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Due to Chronic, Obstructive Pulmonary Disease, Circulating Microvesicles
- What is being tested?
- Catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18
- COPD: obstructive ventilatory insufficient on spirometry and history of smoking
- patients who will perform right heart catheterization
- Signature of written informed consent
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France
Strasbourg, 67091
Marianne RIOU, + 33 369551145, marianne.riou@chru-strasbourg.fr
RIOU Marianne
About this study
Official title: Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
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
- Being tested
- Catheterization
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatheterizationProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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
Circulating markers of endothelium damage with circulating microvesicles will be dosed.
Measured: - 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
Proinflammatory markers with circulating microvesicles will be dosed.
Measured: - 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
Cell stimulation estimated with circulating microvesicles will be dosed.
Measured: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne RIOU, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250128
- Sponsor's protocol ID
- 8073
- Acronym
- MICROBOPH
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05250128
- Acronym / sponsor ID
- MICROBOPH / 8073
- Conditions
- Pulmonary Hypertension Due to Chronic, Obstructive Pulmonary Disease, Circulating Microvesicles, Circulating Markers of Endothelium Damage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18
- COPD: obstructive ventilatory insufficient on spirometry and history of smoking
- patients who will perform right heart catheterization
- Signature of written informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CatheterizationRight heart catheterization, using the Swan-Ganz standard technique, to measure mean pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and pulmonary vascular resistance | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Characterization of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease
Time frame: - 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
Time frame: - 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
Time frame: - During the first hemodynamic assessment by RHC; - At 3 to 6 months, if an hemodynamic control is required (RHC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne RIOU principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension Due to Chronic and Obstructive Pulmonary Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne RIOU (+33 369551145, marianne.riou@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.