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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02637050

Collaborator

(none)

231

Enrollment

Locations

54.5

Actual Duration (Months)

38.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Other: Standard of care

Study Design

Study Type:

Observational

Actual Enrollment :

231 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 3, 2016

Actual Primary Completion Date :

Jul 3, 2020

Actual Study Completion Date :

Sep 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
CTEPH Patients Patients with confirmed diagnosis of CTEPH	Other: Standard of care At the discretion of the attending physician.

Arm

Intervention/Treatment

CTEPH Patients

Patients with confirmed diagnosis of CTEPH

Other: Standard of care

At the discretion of the attending physician.

Outcome Measures

Primary Outcome Measures

The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit [Up to 3 years]
6MWD (6 Minutes Walking Distance)
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 [Up to 3 years]
WHO Functional class (World Health Organization Functional Class)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit [Up to 3 years]
PVR (Pulmonary Vascular Resistance)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit [Up to 3 years]
CI (Cardiac Index)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit [Up to 3 years]
mPAP (mean Pulmonary Arterial Pressure)

Secondary Outcome Measures

Eligibility for PEA [Up to 3 years]
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.
Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy [Up to 3 years]
Not yet assessable/Recurrent/Residual
Time span between onset of symptoms and CTEPH diagnosis [Up to 3 years]
Usage of diagnostic tools of CTEPH patients (Y/N) [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 [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 [Up to 3 years]
Changes in CTEPH treatment during the study period [Up to 3 years]
Number of patients eligible for Pulmonary endarterectomy [Up to 3 years]
NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels [Up to 3 years]
Mortality due to CTEPH and CTEPH related complications [Up to 3 years]
Number of healthcare professional visits due to CTEPH and CTEPH related complications [Up to 3 years]
The total number of days of hospitalization due to CTEPH and CTEPH related complications [Up to 3 years]
Number of patients eligible for Balloon Pulmonary Angioplasty [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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):

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

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

Contacts and Locations

Locations

	City	Country
1	Multiple Locations	Kazakhstan
2	Multiple Locations	Kyrgyzstan
3	Multiple Locations	Lebanon
4	Multiple Locations	Russian Federation
5	Multiple Locations	Saudi Arabia
6	Multiple Locations	Turkey