Trial Condition(s):

Hypertension, Pulmonary

A study investigating routine practice of Chronic Thromboembolic Pulmonary Hypertension management in EMEA countries (EMEA CTEPH)

Bayer Identifier:

18303

ClinicalTrials.gov Identifier:

NCT02637050

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

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
231
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Turkey

Status
Active, not recruiting
Locations

Investigative Site

Many locations, Russia

Status
Active, not recruiting
Locations

Investigative Site

Many locations, Saudi Arabia

Status
Active, not recruiting
Locations

Investigative Site

Many locations, Kazakhstan

Status
Active, not recruiting
Locations

Investigative Site

Many locations, Lebanon

Status
Active, not recruiting
Locations

Investigative Site

Many locations, Kyrgyzstan

Status
Active, not recruiting

Trial Design