Clinical trial NCT02637050: A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries
Official title: EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Type IV Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
CTEPH
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers

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.


Eligibility criteria: 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

Primary outcomes:
measure: The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit
timeFrame: Up to 3 years
measure: 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
timeFrame: Up to 3 years
measure: The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit
timeFrame: Up to 3 years
measure: The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit
timeFrame: Up to 3 years
measure: The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit
timeFrame: Up to 3 years
Secondary outcomes:
measure: Eligibility for PEA
timeFrame: Up to 3 years
measure: Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy
timeFrame: Up to 3 years
measure: Time span between onset of symptoms and CTEPH diagnosis
timeFrame: Up to 3 years
measure: Usage of diagnostic tools of CTEPH patients (Y/N)
timeFrame: Up to 3 years
measure: Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit
timeFrame: Up to 3 years
measure: Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit
timeFrame: Up to 3 years
measure: Changes in CTEPH treatment during the study period
timeFrame: Up to 3 years
measure: Number of patients eligible for Pulmonary endarterectomy
timeFrame: Up to 3 years
measure: NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels
timeFrame: Up to 3 years
measure: Mortality due to CTEPH and CTEPH related complications
timeFrame: Up to 3 years
measure: Number of healthcare professional visits due to CTEPH and CTEPH related complications
timeFrame: Up to 3 years
measure: The total number of days of hospitalization due to CTEPH and CTEPH related complications
timeFrame: Up to 3 years
measure: Number of patients eligible for Balloon Pulmonary Angioplasty
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Kazakhstan
city: Multiple Locations
country: Kyrgyzstan
city: Multiple Locations
country: Lebanon
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Saudi Arabia
city: Multiple Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: