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

Bayer

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Other: Standard of care

Study type: Observational

Funder types: Industry

Identifiers

NCT02637050

18303

AD 1502 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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):

  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

Trial design

231 participants in 1 patient group

CTEPH Patients

Description:

Patients with confirmed diagnosis of CTEPH

Treatment:

Other: Standard of care