A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries

Hypertension, Pulmonary Clinical Trial

— EMEA CTEPH  

Official title:

EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637050
• Other study ID #: 18303
• Secondary ID: AD 1502
• Status: Completed
• Start date: March 3, 2016
• Est. completion date: September 17, 2020

Study information

• Verified date: August 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Other:
• Standard of care
At the discretion of the attending physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Kazakhstan,  Kyrgyzstan,  Lebanon,  Russian Federation,  Saudi Arabia,  Turkey, 

Outcome

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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