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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
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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:
Patients can also receive a combination of these treatments.
The main question this registry aims to answer are:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary endarterectomy | Procedure | Surgical removal of a chronic clot from the pulmonary artery |
| |
| Balloon pulmonary angioplasty | Procedure | Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon |
| |
| 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 |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
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)
Age ≥ 18 years
CTEPH-specific treatment must be modified or initiated at the participating site
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Nick H Kim, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92037 | United States | ||
| Northwestern University |
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| Label | URL |
|---|---|
| Description of the registry on the website of the International CTEPH Association | View source |
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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 |
| 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 |
| 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 |
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 |
| Evanston |
| Illinois |
| 60208 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Hospital Universitario Fundación Favaloro | Buenos Aires | C1093AAS | Argentina |
| University Hospital Vienna | Vienna | 1090 | Austria |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| Santa Casa | Porto Alegre | RS 90035-074 | Brazil |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| China-Japan Friendship Hospital | Beijing | 100020 | China |
| Shaio Clinic Foundation | Bogotá | 111121 | Colombia |
| General University Hospital | Prague | 12808 | Czechia |
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Kerckhoff Clinic, Department of Thoracic Surgery | Bad Nauheim | 61231 | Germany |
| Narayana Institute of Cardiac Science | Bangalore | 560099 | India |
| University of Bologna | Bologna | 40126 | Italy |
| Okayama Medical Center | Okayama | 701-1192 | Japan |
| National Cerebral and Cardiovascular Center | Osaka | 564-8565 | Japan |
| National Heart Institute | Mexico City | 14080 | Mexico |
| Department of Cardiac and Vascular Diseases, John Paul II Hospital | Krakow | 31-202 | Poland |
| Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock | Otwock | 05-400 | Poland |
| National Heart Centre of Singapore | Singapore | 168582 | Singapore |
| Pulmonary Hypertension Unit, Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Marmara University School of Medicine | Istanbul | 34899 | Turkey (Türkiye) |
| Royal Papworth Hospital | Cambridge | CB2 0AY | United Kingdom |