Hypertension, Pulmonary Clinical Trial
— EMEA CTEPHOfficial title:
EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
Verified date | August 2021 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 231 |
Est. completion date | September 17, 2020 |
Est. primary completion date | July 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Kazakhstan, Kyrgyzstan, Lebanon, Russian Federation, Saudi Arabia, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy | Not yet assessable/Recurrent/Residual | Up to 3 years | |
Secondary | Time span between onset of symptoms and CTEPH diagnosis | Up to 3 years | ||
Secondary | Usage of diagnostic tools of CTEPH patients (Y/N) | Up to 3 years | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Changes in CTEPH treatment during the study period | Up to 3 years | ||
Secondary | Number of patients eligible for Pulmonary endarterectomy | Up to 3 years | ||
Secondary | NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels | Up to 3 years | ||
Secondary | Mortality due to CTEPH and CTEPH related complications | Up to 3 years | ||
Secondary | Number of healthcare professional visits due to CTEPH and CTEPH related complications | Up to 3 years | ||
Secondary | The total number of days of hospitalization due to CTEPH and CTEPH related complications | Up to 3 years | ||
Secondary | Number of patients eligible for Balloon Pulmonary Angioplasty | Up to 3 years |
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