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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-03

Study Completion Date

2020-09-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CTEPH Patients

Patients with confirmed diagnosis of CTEPH

Standard of care

Intervention Type OTHER

At the discretion of the attending physician.

Interventions

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Standard of care

At the discretion of the attending physician.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No