Chronic Thromboembolic Pulmonary HypertensionTEAMNCT05629052
TrEatment Approach in the Multimodal Era Registry
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 25 sites in 20 countries.
Trial summary
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, CTEPH
- What is being tested?
- Pulmonary endarterectomy, Balloon pulmonary angioplasty and Pulmonary hypertension (PH)-specific medication
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 25 sitesin 20 countries
- Study dates
- 12 Apr 2023to Apr 2028
- How long will I take part?
- 3 Years
- 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: Patients suffering from CTEPH or CTEPD without PH who are newly referred to an expert center and who meet all of the inclusion criteria and none of the exclusion criteria
Who may be able to join
- Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:
- Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from CTEPD without PH
- Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Naïve to interventional treatment (both PEA and BPA)
- Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
Show all 9Show fewer
- Willing and able to provide informed consent in order to participate in the study (informed consent signed)
- Age ≥ 18 years
- CTEPH-specific treatment must be modified or initiated at the participating site
Who cannot join
- Main cause of PH other than CTEPH
- Participating in an interventional clinical trial at enrollment
Trial locations and contacts
25 sites in 20 countries.
25 sites in 20 countries
United States4 sites
UT Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27705
Northwestern University
Evanston, Illinois, 60208
University of California San Diego
San Diego, California, 92037
Japan2 sites
Okayama Medical Center
Okayama, 701-1192
National Cerebral and Cardiovascular Center
Osaka, 564-8565
Poland2 sites
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, 31-202
Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock
Otwock, 05-400
Argentina1 site
Hospital Universitario Fundación Favaloro
Buenos Aires, C1093AAS
Germany1 site
Kerckhoff Clinic, Department of Thoracic Surgery
Bad Nauheim, 61231
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul, 34899
About this study
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH:
- surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA))
- the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA))
- drugs
Read more
Patients can also receive a combination of these treatments.
The main question this registry aims to answer are:
- How many patients receive a given kind of treatment?
- How do expert centers combine the different treatments?
- Are patients doing better after they receive a given kind of treatment?
- How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment?
Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
- Being tested
- Pulmonary endarterectomy, Balloon pulmonary angioplasty, Pulmonary hypertension (PH)-specific medication
- Keywords
- Chronic thromboembolic pulmonary hypertension, CTEPH, Pulmonary endarterectomy, PEA, Balloon pulmonary angioplasty, BPA, Multimodal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary endarterectomyProcedure or surgery
Also called PEA, Pulmonary thromboendarterectomy (PTE), PTE
Surgical removal of a chronic clot from the pulmonary artery
Balloon pulmonary angioplastyProcedure or surgery
Also called BPA
Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon
Pulmonary hypertension (PH)-specific medicationDrug
Treatment with any PH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization and combination of treatment modalities
Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities
Measured: Min. 3 years
3-year survival
Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Measured: 3 years after last intervention
Secondary outcomes (7)
Complications of treatment interventions (per patient)
Proportion of patients experiencing complications from BPA or PEA
Measured: Min. 3 years
Complications of treatment interventions (per BPA session)
Proportion of BPA sessions associated with complications
Measured: Min. 3 years
1-year survival
Proportion of patients alive 1 year after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Measured: 1 year after last intervention
5-year survival
Proportion of patients alive 5 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Measured: 5 year after last intervention
Changes in PH-specific medication
Proportion of patients experiencing a change in PH-specific medication during the study
Measured: Min. 3 years
Reason why PEA was not performed
The main reason why PEA was not performed as chosen by the investigator from a list of pre-defined reasons
Measured: Min. 3 years
Reason why BPA was not performed
The main reason why BPA was not performed as chosen by the investigator from a list of pre-defined reasons
Measured: Min. 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start12 Apr 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (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.
- 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
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- International CTEPH Association
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nick H Kim, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629052
- Sponsor's protocol ID
- TEAM registry
- Acronym
- TEAM
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrEatment Approach in the Multimodal Era Registry
- ClinicalTrials.gov ID
- NCT05629052
- Acronym / sponsor ID
- TEAM / TEAM registry
- Keywords
- Chronic thromboembolic pulmonary hypertension, CTEPH, Pulmonary endarterectomy, PEA, Balloon pulmonary angioplasty, BPA, Multimodal treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- International CTEPH AssociationUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Nov 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.
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH:
- surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA))
- the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA))
- drugs
Patients can also receive a combination of these treatments.
The main question this registry aims to answer are:
- How many patients receive a given kind of treatment?
- How do expert centers combine the different treatments?
- Are patients doing better after they receive a given kind of treatment?
- How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment?
Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from CTEPH or CTEPD without PH who are newly referred to an expert center and who meet all of the inclusion criteria and none of the exclusion criteria
Key inclusion criteria (9 listed)
- Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Naïve to interventional treatment (both PEA and BPA)
- Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
- Willing and able to provide informed consent in order to participate in the study (informed consent signed)
Key exclusion criteria (2 listed)
- Main cause of PH other than CTEPH
- Participating in an interventional clinical trial at enrollment
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 |
|---|---|---|
| Pulmonary endarterectomyAlso: PEA, Pulmonary thromboendarterectomy (PTE), PTESurgical removal of a chronic clot from the pulmonary artery | Procedure or surgery | – |
| Balloon pulmonary angioplastyAlso: BPACatheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon | Procedure or surgery | – |
| Pulmonary hypertension (PH)-specific medicationTreatment with any PH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists | Drug | – |
Primary outcome
Utilization and combination of treatment modalities
Time frame: Min. 3 years
Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities
3-year survival
Time frame: 3 years after last intervention
Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
7 secondary outcomes
Complications of treatment interventions (per patient)
Time frame: Min. 3 years
Complications of treatment interventions (per BPA session)
Time frame: Min. 3 years
1-year survival
Time frame: 1 year after last intervention
5-year survival
Time frame: 5 year after last intervention
Changes in PH-specific medication
Time frame: Min. 3 years
Reason why PEA was not performed
Time frame: Min. 3 years
Reason why BPA was not performed
Time frame: Min. 3 years
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 26 Oct 2026.
- Description of the registry on the website of the International CTEPH AssociationLink provided by the sponsor.
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. This study is not recruiting at the moment.
Nick H Kim, MD principal investigator
University of California, San Diego
25 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 25 sites in 20 countries.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Japan, Poland, Argentina, Austria and 15 more countries. 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?
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?
Utilization and combination of treatment modalities (time frame: Min. 3 years). The study lists 2 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 26 Oct 2026.