Chronic Pulmonary ThromboembolismCTEPHNCT06865326
Early Detection of CTEPH in Patients After APE
An observational study of Chronic Pulmonary Thromboembolism, run by Institute of Health Information and Statistics of the Czech Republic at 10 sites in Czechia.
Trial summary
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Thromboembolism
- What is being tested?
- Standardized CTEPH Screening Protocol
- How many people
- 500 participants
- Where
- 10 sitesCzechia
- Study dates
- 7 Mar 2025to 30 Jun 2028
- 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: Pacients matching all inclusion \& exclusion criteria
Who may be able to join
- Age over 18 years
- Signed consent to participate in the project and GDPR
- Patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy:
- Patients with new-onset and ongoing or progressive dyspnea (min. NYHA II) after a pulmonary embolism episode or worsening of dyspnea after a pulmonary embolism episode compared to the status before the episode (at least 1 HYHA grade) or
- Asymptomatic patients after a pulmonary embolism episode and at least one of the following risk factors:
- ECHO evidence of severe PH at diagnosis of PE (PASP >60 mmHg)
Show all 13Show fewer
- Antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein I (B2GPI) antibodies + anticardiolipin)
- Infected permanent venous inlets and cardiac pacing/defibrillation intravascular systems
- Presence of ventriculoatrial shunt for treatment of hydrocephalus
- Nonspecific intestinal inflammation (ulcerative colitis, Crohn's disease)
- History of splenectomy
- Myeloproliferative disorders
- Chronic osteomyelitis
Who cannot join
- Not agreeing to participate in the project
- Contraindications to treatment
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lucie Mandelová, PhD contact
10 sites in 1 country
Czechia10 sites, 10 recruiting
- Recruiting
Brno University Hospital
Brno
Marián Felšöci, M.D., felsoci.marian@fnbrno.cz
- Recruiting
Havlíčkův Brod Hospital
Havlíčkův Brod
Dan Bílek, M.D., 420 605 868 202, dan.bilek@onhb.cz
- Recruiting
University Hospital Hradec Králové
Hradec Králové
Filip Varhaník, M.D., filip.varhanik@fnhk.cz
- Recruiting
Jihlava Hospital
Jihlava
Daniel Foldyna, M.D., 420 724 286 063, foldyna.d@seznam.cz
- Recruiting
Náchod Hospital
Náchod
Kamila Roháčková, M.D., 420 720 852 314, rohackova.kamila@nemocnicenachod.cz
- Recruiting
University Hospital Olomouc
Olomouc
Martina Rašková, M.D., 420 737 732 601, martina.raskova@fnol.cz
- Recruiting
University Hospital Ostrava
Ostrava
Jan Mrózek, M.D., 420 777 058 367, jan.mrozek@fno.cz
- Recruiting
Pardubice Hospital
Pardubice
Jiří Vondrák, M.D., 420 605 419 777, jiri.vondrak@nempk.cz
- Recruiting
Rychnov nad Kněžnou Hospital
Rychnov nad Kněžnou
David Muthsam, M.D., 420 777 905 778, muthsam.david@nemocnicerk.cz
- Recruiting
Tábor Hospital
Tábor
Jan Kuchař, M.D., 420 723 465 691, kucharj@seznam.cz
About this study
Official title: Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.
Read the detailed description
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic.
The global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with CTEPH and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. The timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death.
The main objective of this activity is to validate the CTEPH screening process, which will benefit 500 patients in approximately 10 selected centres. Subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. The process will include a review and evaluation of the screening algorithm in patients in the pilot.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002007
- Conditions
- Chronic Pulmonary Thromboembolism
- Being tested
- Standardized CTEPH Screening Protocol
- Keywords
- CTEPH, APE, Early detection, Czech Republic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized CTEPH Screening ProtocolOther
Implementation of a standardized screening algorithm for early detection of CTEPH in patients after Acute Pulmonary Embolism (APE) and establishment of optimized referral of patients to specialized centers.
| Study group | Role | What they receive |
|---|---|---|
| CTEPH Screening Arm | Patients after APE matching all inclusion \& exclusion criteria will undergo a standardized screening process for early detection of CTEPH. The process will include the new screening protocol and in case of a risk of CTEPH, transfer to specialized center for further management. Receives: Other: Standardized CTEPH Screening Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of initial examination
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
Measured: Up to six months from enrollment
CTEPH detection rates
Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the specialized centre.
Measured: Up to six months from enrollment
Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
Measured: Up to six months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start7 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary ThromboembolismStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Pavel Jansa, prof., Study director, General University Hospital of Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865326
- Sponsor's protocol ID
- UZIS 2024/2
- Acronym
- CTEPH
- Status last verified
- Nov 2026
- First submitted
- 2 Dec 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06865326
- Acronym / sponsor ID
- CTEPH / UZIS 2024/2
- Conditions
- Chronic Pulmonary Thromboembolism
- Keywords
- CTEPH, APE, Early detection, Czech Republic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- General University Hospital, Prague
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Mar 2025 (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 project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.
Detailed description
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic.
The global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with CTEPH and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. The timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death.
The main objective of this activity is to validate the CTEPH screening process, which will benefit 500 patients in approximately 10 selected centres. Subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. The process will include a review and evaluation of the screening algorithm in patients in the pilot.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002007
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTEPH Screening Arm | – | Other: Standardized CTEPH Screening ProtocolPatients after APE matching all inclusion \& exclusion criteria will undergo a standardized screening process for early detection of CTEPH. The process will include the new screening protocol and in case of a risk of CTEPH, transfer to specialized center for further management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pacients matching all inclusion \& exclusion criteria
Key inclusion criteria (13 listed)
- Age over 18 years
- Signed consent to participate in the project and GDPR
- Patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy:
- ECHO evidence of severe PH at diagnosis of PE (PASP >60 mmHg)
- Antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein I (B2GPI) antibodies + anticardiolipin)
Key exclusion criteria (2 listed)
- Not agreeing to participate in the project
- Contraindications to treatment
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 |
|---|---|---|
| Standardized CTEPH Screening ProtocolImplementation of a standardized screening algorithm for early detection of CTEPH in patients after Acute Pulmonary Embolism (APE) and establishment of optimized referral of patients to specialized centers. | Other | CTEPH Screening Arm |
Primary outcome
Positive predictive value of initial examination
Time frame: Up to six months from enrollment
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
CTEPH detection rates
Time frame: Up to six months from enrollment
Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the specialized centre.
Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre
Time frame: Up to six months from enrollment
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
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 4 Nov 2026.
Related trials for Chronic Pulmonary Thromboembolism
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Chronic Thromboembolic Disease Registry
Chronic Thromboembolic Pulmonary Hypertension, Chronic Thromboembolic Disease
Active, not recruitingObservational study
FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
Deep Venous Thrombosis, Pulmonary Embolism
Not yet recruitingPhase 2
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,
Anesthesia, Pulmonary Hypertension
Recruiting
Functional Pulmonary Capillary Surface Area in BPA for CTEPH
Hypertension, Pulmonary, Pulmonary Thromboembolisms
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.
Lucie Mandelová, PhD contact
Pavel Jansa, prof. study director
General University Hospital of Prague
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pulmonary Thromboembolism, run by Institute of Health Information and Statistics of the Czech Republic at 10 sites in Czechia.
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 13 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Czechia. 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 Nikola Štourač (+420 739 012 354, nikola.stourac@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of initial examination (time frame: Up to six months from enrollment). The study lists 3 primary outcomes in all. 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 4 Nov 2026.