Trial Condition(s):
Hypertension, Pulmonary
A study investigating routine practice of Chronic Thromboembolic Pulmonary Hypertension management in EMEA countries (EMEA CTEPH)
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.
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): a. 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 b. 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Many locations, Turkey | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Many locations, Russia | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Many locations, Saudi Arabia | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Many locations, Kazakhstan | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Many locations, Lebanon | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Many locations, Kyrgyzstan | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
EMEA CTEPH Registry: An international prospective registry investigating the epidemiology, diagnosis and treatment of CTEPH patients in EMEA countries
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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)Timeframe: 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 visitWHO Functional class (World Health Organization Functional Class)Timeframe: 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 visitPVR (Pulmonary Vascular Resistance)Timeframe: 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 visitCI (Cardiac Index)Timeframe: 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 visitmPAP (mean Pulmonary Arterial Pressure)Timeframe: Up to 3 years
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.Timeframe: Up to 3 years
- Rate of recurrent to persistent subtypes after Pulmonary EndarterectomyNot yet assessable/Recurrent/ResidualTimeframe: Up to 3 years
- Time span between onset of symptoms and CTEPH diagnosisTimeframe: Up to 3 years
- Usage of diagnostic tools of CTEPH patients (Y/N)Timeframe: 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 visitTimeframe: 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 visitTimeframe: Up to 3 years
- Changes in CTEPH treatment during the study periodTimeframe: Up to 3 years
- Number of patients eligible for Pulmonary endarterectomyTimeframe: Up to 3 years
- NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levelsTimeframe: Up to 3 years
- Mortality due to CTEPH and CTEPH related complicationsTimeframe: Up to 3 years
- Number of healthcare professional visits due to CTEPH and CTEPH related complicationsTimeframe: Up to 3 years
- The total number of days of hospitalization due to CTEPH and CTEPH related complicationsTimeframe: Up to 3 years
- Number of patients eligible for Balloon Pulmonary AngioplastyTimeframe: Up to 3 years
Additional Information
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