TrEatment Approach in the Multimodal Era Registry

NCT05629052 | Active Not Recruiting DMC

• 1 other identifier: TEAM registry
• Study Type: observational
• Target: 1,000
• Locations: 20 countries
• Sites: 25

Brief 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. 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; CTEPH

Keywords

Chronic thromboembolic pulmonary hypertension; CTEPH; Pulmonary endarterectomy; PEA; Balloon pulmonary angioplasty; BPA; Multimodal treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Complications of treatment interventions (per patient)

  Min. 3 years

• Complications of treatment interventions (per BPA session)

  Min. 3 years

• 1-year survival

  1 year after last intervention

• 5-year survival

  5 year after last intervention

• Changes in PH-specific medication

  Min. 3 years

Other Outcomes (4)

• Number of unplanned hospitalizations

  Min. 3 years

• Timing of unplanned hospitalizations

  Min. 3 years

• Frequency of QoL assessment

  Min. 3 years

Interventions

Pulmonary endarterectomy PROCEDURE

Surgical removal of a chronic clot from the pulmonary artery

Also known as: PEA, Pulmonary thromboendarterectomy (PTE), PTE

Balloon pulmonary angioplasty PROCEDURE

Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon

Also known as: BPA

Pulmonary hypertension (PH)-specific medication DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• Main cause of PH other than CTEPH
• Participating in an interventional clinical trial at enrollment

Sponsors & Collaborators

• International CTEPH Association: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (25)

University of California San Diego

San Diego, California, 92037, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Hospital Universitario Fundación Favaloro

Buenos Aires, C1093AAS, Argentina

Location

University Hospital Vienna

Vienna, 1090, Austria

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Santa Casa

Porto Alegre, RS 90035-074, Brazil

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

China-Japan Friendship Hospital

Beijing, 100020, China

Location

Shaio Clinic Foundation

Bogotá, 111121, Colombia

Location

General University Hospital

Prague, 12808, Czechia

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Kerckhoff Clinic, Department of Thoracic Surgery

Bad Nauheim, 61231, Germany

Location

Narayana Institute of Cardiac Science

Bangalore, 560099, India

Location

University of Bologna

Bologna, 40126, Italy

Location

Okayama Medical Center

Okayama, 701-1192, Japan

Location

National Cerebral and Cardiovascular Center

Osaka, 564-8565, Japan

Location

National Heart Institute

Mexico City, 14080, Mexico

Location

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, 31-202, Poland

Location

Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock

Otwock, 05-400, Poland

Location

National Heart Centre of Singapore

Singapore, 168582, Singapore

Location

Pulmonary Hypertension Unit, Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Marmara University School of Medicine

Istanbul, 34899, Turkey (Türkiye)

Location

Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

Related Links

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

Study Officials

• Nick H Kim, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: April 12, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

AR (1); CZ (1); TU (1); BE (1); CO (1); IN (1); ME (1); SG (1); DK (1); DE (1); JP (2); US (4); CA (1); ES (1); BR (1); IT (1); GB (1); CN (1); AU (1); PL (2)