Hypertension, Pulmonary
Conditions
Keywords
Type IV Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, CTEPH
Brief summary
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.
Interventions
OTHERStandard of care
At the discretion of the attending physician.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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): 1. Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels: * Mean pulmonary arterial pressure (PAP) ≥ 25 mmHg at rest * Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg 2. Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines: * At least 1 (segmental) perfusion defect(s) in ventilation/perfusion (V/Q) scan or * Pulmonary artery obstruction seen by MDCT (multidetector computed tomography) angiography or * Pulmonary artery obstruction seen by conventional pulmonary cineangiography (In case of suspicion/diagnosis of 'sub-acute' Pulmonary Embolism: Patients who are treated with anti-coagulation for at least 3 months before diagnosis of CTEPH)
Exclusion criteria
* Patients with an underlying medical disorder with an anticipated life expectancy less than 6 months * Any medical condition which, in the opinion of the investigator, could jeopardize the safety of the patient or his/her compliance in the study, or otherwise make the patient inappropriate for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit | Up to 3 years | CI (Cardiac Index) |
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit | Up to 3 years | mPAP (mean Pulmonary Arterial Pressure) |
| The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit | Up to 3 years | 6MWD (6 Minutes Walking Distance) |
| 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 | Up to 3 years | WHO Functional class (World Health Organization Functional Class) |
| The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit | Up to 3 years | PVR (Pulmonary Vascular Resistance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Eligibility for PEA | Up to 3 years | 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. |
| 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 | — |
| Mortality due to CTEPH and CTEPH related complications | Up to 3 years | — |
| Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy | Up to 3 years | Not yet assessable/Recurrent/Residual |
| 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 | — |
Countries
Kazakhstan, Kyrgyzstan, Lebanon, Russia, Saudi Arabia, Turkey (Türkiye)
Outcome results
None listed