Chronic Thromboembolic Pulmonary HypertensionPROTEO-CTEPHNCT05340023
Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- blood sample
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2022to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will be offered to all consecutive patients admitted to the participating competence centers, provided they meet the the study, provided they meet the inclusion criteria and have no non-inclusion criteria.
Who may be able to join
- Patient with a suspicion of Chronic thromboembolic pulmonary hypertension (CTEPH) with a combination of a perfusion lung scan and transthoracic perfusion scan and transthoracic echocardiography compatible with the diagnosis (according to French recommendations)
- Patients who require a right heart catheterization.
- Patient affiliated or entitled to a social security plan
- Patient having received informed information about the study informed about the study
Who cannot join
- Patient with a normal perfusion lung scan
- Person under legal guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de SAINT-ETIENNE
Saint-Etienne, 42055
Laurent BERTOLETTI, MD PhD
About this study
Official title: Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension : PROTEO-CTEPH Study.
Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic echo (TTE) must be evaluated in Pulmonary Hypertension (PH)-centers with right heart catheterism, to confirm or rule out the presence of precapillary Pulmonary Hypertension (PH), and precise the group of Pulmonary Hypertension (PH).
Read the detailed description
However, persistent dyspnea and perfusion defects are frequent after pulmonary embolism (PE), and the accuracy of transthoracic echo (TTE) is not great for precapillary Pulmonary Hypertension (PH).
This study proposed to seek for a specific proteomic pattern in patients admitted for a suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH).
- Being tested
- blood sample
- Keywords
- Pulmonary hypertension;, chronic thromboembolic pulmonary hypertension, pulmonary embolism, proteomic pattern
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
to realize proteomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) | * right cardiac catheterization (usual practice)
* a blood sample (inclusion for all patients with suspicion)
* if diagnosis of Chronic thromboembolic pulmonary hypertension confirmed a another bood sample at 6 months Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH)
Analysis of the final diagnosis retained for the patient : Chronic thromboembolic pulmonary hypertension (CTEPH) (population of interest), pre-capillary Pulmonary Hypertension (PH) other than Chronic thromboembolic pulmonary hypertension (CTEPH), post-capillary Pulmonary Hypertension (PH), no Pulmonary Hypertension (PH).
Measured: Day: 0
Secondary outcomes (7)
Analysis of recording of hemodynamic data at diagnosis
hemodynamic data : pulmonary vascular resistance, cardiac index, pulmonary arterial pressures
Measured: Day: 0
Analysis of recording of hemodynamic data at diagnosis
hemodynamic data : pulmonary vascular resistance,
Measured: Day: 0
Analysis of recording of hemodynamic data at diagnosis
hemodynamic data : cardiac index
Measured: Day: 0
Analysis of recording of hemodynamic data at diagnosis
hemodynamic data : pulmonary arterial pressures
Measured: Day: 0
Analysis of recording of hemodynamic after 6 months of treatment
hemodynamic data : pulmonary vascular resistance,
Measured: 6 months
Analysis of recording of hemodynamic after 6 months of treatment
hemodynamic data : cardiac index
Measured: 6 months
Analysis of recording of hemodynamic data at diagnosis and at death
hemodynamic data : pulmonary arterial pressures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start9 Nov 2022
- Primary completionJun 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BERTOLETTI, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340023
- Sponsor's protocol ID
- 21CH115
- Other IDs
- ANSM
- Acronym
- PROTEO-CTEPH
- Status last verified
- Jul 2025
- First submitted
- 17 Nov 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension : PROTEO-CTEPH Study.
- ClinicalTrials.gov ID
- NCT05340023
- Acronym / sponsor ID
- PROTEO-CTEPH / 21CH115
- Keywords
- Pulmonary hypertension;, chronic thromboembolic pulmonary hypertension, pulmonary embolism, proteomic pattern
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Apr 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.
Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic echo (TTE) must be evaluated in Pulmonary Hypertension (PH)-centers with right heart catheterism, to confirm or rule out the presence of precapillary Pulmonary Hypertension (PH), and precise the group of Pulmonary Hypertension (PH).
Detailed description
However, persistent dyspnea and perfusion defects are frequent after pulmonary embolism (PE), and the accuracy of transthoracic echo (TTE) is not great for precapillary Pulmonary Hypertension (PH).
This study proposed to seek for a specific proteomic pattern in patients admitted for a suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) | – | Biological: blood sample* right cardiac catheterization (usual practice) * a blood sample (inclusion for all patients with suspicion) * if diagnosis of Chronic thromboembolic pulmonary hypertension confirmed a another bood sample at 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be offered to all consecutive patients admitted to the participating competence centers, provided they meet the the study, provided they meet the inclusion criteria and have no non-inclusion criteria.
Key inclusion criteria (4 listed)
- Patient with a suspicion of Chronic thromboembolic pulmonary hypertension (CTEPH) with a combination of a perfusion lung scan and transthoracic perfusion scan and transthoracic echocardiography compatible with the diagnosis (according to French recommendations)
- Patients who require a right heart catheterization.
- Patient affiliated or entitled to a social security plan
- Patient having received informed information about the study informed about the study
Key exclusion criteria (2 listed)
- Patient with a normal perfusion lung scan
- Person under legal guardianship
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 |
|---|---|---|
| blood sampleto realize proteomic analysis. | Biological | Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) |
Primary outcome
Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: Day: 0
Analysis of the final diagnosis retained for the patient : Chronic thromboembolic pulmonary hypertension (CTEPH) (population of interest), pre-capillary Pulmonary Hypertension (PH) other than Chronic thromboembolic pulmonary hypertension (CTEPH), post-capillary Pulmonary Hypertension (PH), no Pulmonary Hypertension (PH).
7 secondary outcomes
Analysis of recording of hemodynamic data at diagnosis
Time frame: Day: 0
Analysis of recording of hemodynamic data at diagnosis
Time frame: Day: 0
Analysis of recording of hemodynamic data at diagnosis
Time frame: Day: 0
Analysis of recording of hemodynamic data at diagnosis
Time frame: Day: 0
Analysis of recording of hemodynamic after 6 months of treatment
Time frame: 6 months
Analysis of recording of hemodynamic after 6 months of treatment
Time frame: 6 months
Analysis of recording of hemodynamic data at diagnosis and at death
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
Laurent BERTOLETTI, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Chronic Thromboembolic Pulmonary Hypertension, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent BERTOLETTI, MD PhD ((0)477127770 ext. +33, laurent.bertoletti@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH) (time frame: Day: 0). 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 24 Nov 2025.