check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
18303
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study investigating routine practice of Chronic Thromboembolic Pulmonary Hypertension management in EMEA countries
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
231Trial Dates
March 2016 - September 2020Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many locations, Turkey | |
Active, not recruiting | Many locations, Russia | |
Active, not recruiting | Many locations, Saudi Arabia | |
Active, not recruiting | Many locations, Kazakhstan | |
Active, not recruiting | Many locations, Lebanon | |
Withdrawn | Many locations, United Arab Emirates | |
Withdrawn | Many locations, Algeria | |
Active, not recruiting | Many locations, Kyrgyzstan |
Primary Outcome
- The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit6MWD (6 Minutes Walking Distance)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of WHO Functional Class between initial and final visitWHO Functional class (World Health Organization Functional Class)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visitPVR (Pulmonary Vascular Resistance)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visitCI (Cardiac Index)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visitmPAP (mean Pulmonary Arterial Pressure)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Eligibility for PEAAt 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.date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Rate of recurrent to persistent subtypes after Pulmonary EndarterectomyNot yet assessable/Recurrent/Residualdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Time span between onset of symptoms and CTEPH diagnosisdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Usage of diagnostic tools of CTEPH patients (Y/N)date_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visitdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visitdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Changes in CTEPH treatment during the study perioddate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Number of patients eligible for Pulmonary endarterectomydate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levelsdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Mortality due to CTEPH and CTEPH related complicationsdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Number of healthcare professional visits due to CTEPH and CTEPH related complicationsdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- The total number of days of hospitalization due to CTEPH and CTEPH related complicationsdate_rangeTime Frame:Up to 3 yearsenhanced_encryptionNoSafety Issue:
- Number of patients eligible for Balloon Pulmonary Angioplastydate_rangeTime Frame:Up to 3 years
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A