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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05629052
Other study ID # TEAM registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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