Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Preva-CTEPHNCT03719027
Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)
A study testing Study population in people with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Embolism
- What is being tested?
- Study population
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,003 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Oct 2018to 29 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients older than 18 years
- Pulmonary embolism objectively confirmed
- Treated during at least 3 months with curative anticoagulant
- Previously included since at least 1 year in one of the studies of the INNOVTE network
- affiliated to the national social security
- after written informed consent
Who cannot join
- Patients with an objectively confirmed CTEPH before the diagnosis of index PE
- Follow-up impossible
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Jean Minjoz
Besançon
La Cavale Blanche
Brest
Hôpital européen Georges-Pompidou
Paris, 75015
Hôpital Nord
Saint-Etienne
About this study
Official title: Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study
The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.
The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.
Read the detailed description
The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network.
Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA >1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines.
Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase.
For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved.
All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.
- Being tested
- Study population
- Keywords
- Prevalence and incidence of CTEPH after pulmonary embolism, history of diagnosis
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study populationDiagnostic test
Dyspnea assessment (NYHA functional class) EKG Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Patients followed-up after the diagnosis of pulmonary embolism (PE) Patients who survived after a PE and who consent to participate to the prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH Receives: Diagnostic Test: Study population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated incidence of CTEPH
Cumulated incidence rate of CTEPH after pulmonary embolism
Measured: 30-day +/- 15 days after inclusion visit
Secondary outcomes (5)
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
Cumulated incidence rate of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
Measured: 30-day +/- 15 days after inclusion visit
Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Cumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Measured: 30-day +/- 15 days after inclusion visit
Risk factors of CTEPH
Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism
Measured: 30-day +/- 15 days after inclusion visit
Complications associated with right heart catheterization
Complication rate of right heart catheterization
Measured: 30-day +/- 15 days after inclusion visit
Complications associated with pulmonary angiography
Complication rate of pulmonary angiography
Measured: 30-day +/- 15 days after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start30 Oct 2018
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective and prospective cohort study
- Masking
- None (open label)
- Enrolment
- 2,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Olivier SANCHEZ, MD, PhD, Principal investigator, Université Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719027
- Sponsor's protocol ID
- K161203J
- Other IDs
- 2017-A02047-46
- Acronym
- Preva-CTEPH
- Status last verified
- May 2024
- First submitted
- 23 Oct 2018
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE
Publications
Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
PubMed 24898545Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, Delcroix M, Pruszczyk P, Mairuhu AT, Huisman MV, Klok FA. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017 Feb 23;49(2):1601792. doi: 10.1183/13993003.01792-2016. Print 2017 Feb.
PubMed 28232411
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study
- ClinicalTrials.gov ID
- NCT03719027
- Acronym / sponsor ID
- Preva-CTEPH / K161203J
- Keywords
- Prevalence and incidence of CTEPH after pulmonary embolism, history of diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,003 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 25 Oct 2018 (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.
The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.
The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.
Detailed description
The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network.
Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA >1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines.
Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase.
For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved.
All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective and prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Diagnostic Test: Study populationPatients followed-up after the diagnosis of pulmonary embolism (PE) Patients who survived after a PE and who consent to participate to the prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years
- Pulmonary embolism objectively confirmed
- Treated during at least 3 months with curative anticoagulant
- Previously included since at least 1 year in one of the studies of the INNOVTE network
- affiliated to the national social security
Key exclusion criteria (2 listed)
- Patients with an objectively confirmed CTEPH before the diagnosis of index PE
- Follow-up impossible
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 |
|---|---|---|
| Study populationDyspnea assessment (NYHA functional class) EKG Echocardiography | Diagnostic test | Study population |
Primary outcome
Cumulated incidence of CTEPH
Time frame: 30-day +/- 15 days after inclusion visit
Cumulated incidence rate of CTEPH after pulmonary embolism
5 secondary outcomes
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
Time frame: 30-day +/- 15 days after inclusion visit
Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Time frame: 30-day +/- 15 days after inclusion visit
Risk factors of CTEPH
Time frame: 30-day +/- 15 days after inclusion visit
Complications associated with right heart catheterization
Time frame: 30-day +/- 15 days after inclusion visit
Complications associated with pulmonary angiography
Time frame: 30-day +/- 15 days after inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Results publication: PubMed 24898545Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
- Results publication: PubMed 28232411Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, Delcroix M, Pruszczyk P, Mairuhu AT, Huisman MV, Klok FA. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017 Feb 23;49(2):1601792. doi: 10.1183/13993003.01792-2016. Print 2017 Feb.
- Individual participant dataSharing planned: Undecided. Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE
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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.
Olivier SANCHEZ, MD, PhD principal investigator
Université Paris Descartes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study population in people with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 6 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated incidence of CTEPH (time frame: 30-day +/- 15 days after inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719027, which also lists 2 linked publications.
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 3 May 2024.