An observational study in Hypertension, Pulmonary, sponsored by Bayer. Completed at 6 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Bayer · 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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 231 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
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:
Patients with confirmed diagnosis of CTEPH
Other: Standard of care
At the discretion of the attending physician.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy
Not yet assessable/Recurrent/Residual
Time frame: Up to 3 years
Time span between onset of symptoms and CTEPH diagnosis
Time frame: Up to 3 years
Usage of diagnostic tools of CTEPH patients (Y/N)
Time frame: 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
Time frame: 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
Time frame: Up to 3 years
Changes in CTEPH treatment during the study period
Time frame: Up to 3 years
Number of patients eligible for Pulmonary endarterectomy
Time frame: Up to 3 years
NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels
Time frame: Up to 3 years
Mortality due to CTEPH and CTEPH related complications
Time frame: Up to 3 years
Number of healthcare professional visits due to CTEPH and CTEPH related complications
Time frame: Up to 3 years
The total number of days of hospitalization due to CTEPH and CTEPH related complications
Time frame: Up to 3 years
Number of patients eligible for Balloon Pulmonary Angioplasty
Time frame: Up to 3 years
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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