Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AD 1502 | Other Identifier | Company Internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTEPH Patients | Patients with confirmed diagnosis of CTEPH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | At the discretion of the attending physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit | 6MWD (6 Minutes Walking Distance) | Up to 3 years |
| The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of WHO Functional Class between initial and final visit | WHO Functional class (World Health Organization Functional Class) | Up to 3 years |
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit | PVR (Pulmonary Vascular Resistance) | Up to 3 years |
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit | CI (Cardiac Index) | Up to 3 years |
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit | mPAP (mean Pulmonary Arterial Pressure) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility for PEA | At inclusion, information will be collected for each patient regarding their eligibility for PEA. If eligible, details about the PEA will be recorded; if not eligible, further information will be collected to understand why the patient was not eligible. | Up to 3 years |
| Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy |
Not provided
Inclusion Criteria:
Female and male patients ≥ 18 years of age, diagnosed with CTEPH regardless of the current treatment
Availability of a signed informed consent
WHO Pulmonary Hypertension clinical classification Group IV (CTEPH):
Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:
Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:
Exclusion Criteria:
Not provided
Not provided
Not provided
CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Kazakhstan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38381283 | Derived | Ongen HG, Akdeniz B, Duzenli MA, Chernyavsky A, Dabar G, Idrees M, Khludeeva E, Kultursay H, Lukianchikova V, Martynyuk T, Mogulkoc N, Mukarov MA, Mutlu B, Okumus G, Omarov A, Onen ZP, Sakkijha H, Shostak N, Simakova M, Tokgozoglu L, Tomskaya T, Yildirim H, Zateyshchikov D, Hechenbichler K, Kessner S, Schauerte I, Turgut N, Vogtlander K, Aldalaan A; CTEPH EMEA Registry Investigators. Diagnosis and Treatment Patterns of Chronic Thromboembolic Pulmonary Hypertension in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia: A Registry Study. Drugs Real World Outcomes. 2024 Mar;11(1):149-165. doi: 10.1007/s40801-023-00407-w. Epub 2024 Feb 21. |
Not provided
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not yet assessable/Recurrent/Residual |
| Up to 3 years |
| Time span between onset of symptoms and CTEPH diagnosis | Up to 3 years |
| Usage of diagnostic tools of CTEPH patients (Y/N) | Up to 3 years |
| Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit | Up to 3 years |
| Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit | Up to 3 years |
| Changes in CTEPH treatment during the study period | Up to 3 years |
| Number of patients eligible for Pulmonary endarterectomy | Up to 3 years |
| NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels | Up to 3 years |
| Mortality due to CTEPH and CTEPH related complications | Up to 3 years |
| Number of healthcare professional visits due to CTEPH and CTEPH related complications | Up to 3 years |
| The total number of days of hospitalization due to CTEPH and CTEPH related complications | Up to 3 years |
| Number of patients eligible for Balloon Pulmonary Angioplasty | Up to 3 years |
| Multiple Locations |
| Kyrgyzstan |
| Multiple Locations | Lebanon |
| Multiple Locations | Russia |
| Multiple Locations | Saudi Arabia |
| Multiple Locations | Turkey (Türkiye) |
| D002318 |
| Cardiovascular Diseases |