TrEatment Approach in the Multimodal Era Registry (TEAM)

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 Overview

• Status: Active, not recruiting
• Conditions: Chronic Thromboembolic Pulmonary Hypertension; CTEPH
• Intervention / Treatment: Procedure: Pulmonary endarterectomy; Procedure: Balloon pulmonary angioplasty; Drug: Pulmonary hypertension (PH)-specific medication

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • Hospital Universitario Fundacion Favaloro
• Austria
  • Vienna, Austria, 1090
    • University Hospital Vienna
• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• Brazil
  • Porto Alegre, Brazil, RS 90035-074
    • Santa Casa
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• China
  • Beijing, China, 100020
    • China-Japan Friendship Hospital
• Colombia
  • Bogotá, Colombia, 111121
    • Shaio Clinic Foundation
• Czech Republic
  • Prague, Czech Republic, 12808
    • General University Hospital
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Clinic, Department of Thoracic Surgery
• India
  • Bangalore, India, 560099
    • Narayana Institute of Cardiac Science
• Italy
  • Bologna, Italy, 40126
    • University of Bologna
• Japan
  • Okayama, Japan, 701-1192
    • Okayama Medical Center
  • Osaka, Japan, 564-8565
    • National Cerebral and Cardiovascular Center
• Mexico
  • Mexico City, Mexico, 14080
    • National Heart Institute
• Poland
  • Kraków, Poland, 31-202
    • Department of Cardiac and Vascular Diseases, John Paul II Hospital
  • Otwock, Poland, 05-400
    • Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock
• Singapore
  • Singapore, Singapore, 168582
    • National Heart Centre of Singapore
• Spain
  • Madrid, Spain, 28041
    • Pulmonary Hypertension Unit, Hospital 12 de Octubre
• Turkey
  • Istanbul, Turkey, 34899
    • Marmara University School of Medicine
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Royal Papworth Hospital
• United States
  • California
    • San Diego, California, United States, 92037
      • University Of California San Diego
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:

   1. 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
   2. Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
3. Naïve to interventional treatment (both PEA and BPA)
4. Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
5. Willing and able to provide informed consent in order to participate in the study (informed consent signed)
6. Age ≥ 18 years
7. CTEPH-specific treatment must be modified or initiated at the participating site

Exclusion Criteria:

1. Main cause of PH other than CTEPH
2. Participating in an interventional clinical trial at enrollment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization and combination of treatment modalities	Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities	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	3 years after last intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of treatment interventions (per patient)	Proportion of patients experiencing complications from BPA or PEA	Min. 3 years
Complications of treatment interventions (per BPA session)	Proportion of BPA sessions associated with complications	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	1 year after last intervention
Changes in PH-specific medication	Proportion of patients experiencing a change in PH-specific medication during the study	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	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	Min. 3 years
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	5 year after last intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unplanned hospitalizations	Proportion of patients experiencing an unplanned hospitalization (i.e. not considering planned hospitalizations for study procedures such as PEA or BPA)	Min. 3 years
Timing of unplanned hospitalizations	Analysis of the timing of unplanned hospitalization for patients experiencing an unplanned hospitalization (i.e. not considering planned hospitalizations for study procedures such as PEA or BPA)	Min. 3 years
Frequency of QoL assessment	Proportion of patients undergoing QoL assessment by means of a validated questionnaire during the study	Min. 3 years
Type of QoL questionnaire	Proportion of patients undergoing QoL assessment using a certain validated questionnaire during the study	Min. 3 years

Collaborators and Investigators

• Sponsor: International CTEPH Association
• Collaborators: Janssen Pharmaceuticals
• Investigators: Principal Investigator: Nick H Kim, MD, University of California, San Diego

Publications and helpful links

Helpful Links

• Description of the registry on the website of the International CTEPH Association

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic thromboembolic pulmonary hypertension; PEA; CTEPH; Pulmonary endarterectomy; Balloon pulmonary angioplasty; BPA; Multimodal treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: TEAM registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No