Early detection of chronic thromboembolic pulmonary hypertension after a pulmonary embolism
Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism
This project will test a standardized screening program to see if it finds chronic thromboembolic pulmonary hypertension (CTEPH) earlier in adults who had an acute pulmonary embolism 3–12 months earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic Government |
| Locations | 10 sites (Brno and 9 other locations) |
| Trial ID | NCT06865326 on ClinicalTrials.gov |
What this trial studies
This is a national, prospective, multicenter observational pilot screening about 500 adults across roughly 10 Czech centers using a standardized CTEPH screening protocol. Eligible participants are adults on anticoagulation who had an acute pulmonary embolism 3–12 months earlier and either have new or worsening dyspnea or predefined risk factors for CTEPH. The protocol uses echocardiography and an algorithm-driven pathway for rapid referral to specialized pulmonary hypertension centers for confirmatory testing and treatment where indicated. The project will validate the screening workflow, measure feasibility and patient flow, and review cost-effectiveness before broader implementation.
Who should consider this trial
Good fit: Adults aged 18 or older who are on anticoagulation and had an acute pulmonary embolism 3–12 months ago with new or worsening dyspnea or at least one high-risk feature for CTEPH are the ideal candidates.
Not a fit: People under 18, those outside the 3–12 month post-embolism window, asymptomatic patients without risk factors, or patients unable to attend participating Czech centers are unlikely to benefit from this screening pilot.
Why it matters
Potential benefit: If successful, the program could diagnose CTEPH earlier so patients receive timely specialist care that improves quality of life and reduces complications and risk of death.
How similar studies have performed: Targeted screening and rapid referral for CTEPH after pulmonary embolism have shown benefit in prior single-center and observational cohorts, but a standardized national multicenter pilot like this is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. 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 2. 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) * 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 Exclusion Criteria: * Not agreeing to participate in the project * Contraindications to treatment
Where this trial is running
Brno and 9 other locations
- Brno University Hospital — Brno, Czechia (Recruiting)
- Havlíčkův Brod Hospital — Havlíčkův Brod, Czechia (Recruiting)
- University Hospital Hradec Králové — Hradec Králové, Czechia (Recruiting)
- Jihlava Hospital — Jihlava, Czechia (Recruiting)
- Náchod Hospital — Náchod, Czechia (Recruiting)
- University Hospital Olomouc — Olomouc, Czechia (Recruiting)
- University Hospital Ostrava — Ostrava, Czechia (Recruiting)
- Pardubice Hospital — Pardubice, Czechia (Recruiting)
- Rychnov nad Kněžnou Hospital — Rychnov nad Kněžnou, Czechia (Recruiting)
- Tábor Hospital — Tábor, Czechia (Recruiting)
Study contacts
- Study coordinator: Kateřina Ondrášková, Msc
- Email: katerina.ondraskova@uzis.cz
- Phone: 604603143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.