TrEatment Approach in the Multimodal Era Registry

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— TEAM  

Official title:

TrEatment Approach in the Multimodal Era Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629052
• Other study ID #: TEAM registry
• Status: Recruiting
• Start date: April 12, 2023
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: International CTEPH Association
• Contact: Sonja Mariotti, PhD
• Phone: + 41 41 379 79 70
• Email: sonja.mariotti[@]cteph-association.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• CTEPH
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• Pulmonary endarterectomy
Surgical removal of a chronic clot from the pulmonary artery
• Balloon pulmonary angioplasty
Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon

Drug:
• Pulmonary hypertension (PH)-specific medication
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

Locations

Country	Name	City	State
Argentina	Hospital Universitario Fundación Favaloro	Buenos Aires
Austria	University Hospital Vienna	Vienna
Belgium	University Hospitals Leuven	Leuven
Brazil	Santa Casa	Porto Alegre
Canada	Toronto General Hospital	Toronto	Ontario
China	China-Japan Friendship Hospital	Beijing
Colombia	Shaio Clinic Foundation	Bogotá
Denmark	Aarhus University Hospital	Aarhus
Germany	Kerckhoff Clinic, Department of Thoracic Surgery	Bad Nauheim
India	Narayana Institute of Cardiac Science	Bangalore
Italy	University of Bologna	Bologna
Japan	Okayama Medical Center	Okayama
Mexico	National Heart Institute	Mexico City
Poland	Department of Cardiac and Vascular Diseases, John Paul II Hospital	Kraków
Poland	Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock	Otwock
Singapore	National Heart Centre of Singapore	Singapore
Spain	Pulmonary Hypertension Unit, Hospital 12 de Octubre	Madrid
Turkey	Marmara University School of Medicine	Istanbul
United Kingdom	Royal Papworth Hospital	Cambridge
United States	UT Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Northwestern University	Evanston	Illinois
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
International CTEPH Association	Janssen Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Denmark,  Germany,  India,  Italy,  Japan,  Mexico,  Poland,  Singapore,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Frequency of QoL assessment	Proportion of patients undergoing QoL assessment by means of a validated questionnaire during the study	Min. 3 years
Other	Type of QoL questionnaire	Proportion of patients undergoing QoL assessment using a certain validated questionnaire during the study	Min. 3 years
Primary	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
Primary	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	Complications of treatment interventions (per patient)	Proportion of patients experiencing complications from BPA or PEA	Min. 3 years
Secondary	Complications of treatment interventions (per BPA session)	Proportion of BPA sessions associated with complications	Min. 3 years
Secondary	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
Secondary	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
Secondary	Changes in PH-specific medication	Proportion of patients experiencing a change in PH-specific medication during the study	Min. 3 years
Secondary	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
Secondary	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

External Links

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