check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

18303

ClinicalTrials.gov Identifier:

NCT02637050

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study investigating routine practice of Chronic Thromboembolic Pulmonary Hypertension management in EMEA countries

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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)
  • - 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
March 2016 - September 2020
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many locations, Turkey
Active, not recruiting
Many locations, Russia
Active, not recruiting
Many locations, Saudi Arabia
Active, not recruiting
Many locations, Kazakhstan
Active, not recruiting
Many locations, Lebanon
Withdrawn
Many locations, United Arab Emirates
Withdrawn
Many locations, Algeria
Active, not recruiting
Many locations, Kyrgyzstan

Primary Outcome

  • The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit
    6MWD (6 Minutes Walking Distance)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • 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
    WHO Functional class (World Health Organization Functional Class)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit
    PVR (Pulmonary Vascular Resistance)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit
    CI (Cardiac Index)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit
    mPAP (mean Pulmonary Arterial Pressure)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Eligibility for PEA
    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.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy
    Not yet assessable/Recurrent/Residual
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Time span between onset of symptoms and CTEPH diagnosis
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Usage of diagnostic tools of CTEPH patients (Y/N)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Changes in CTEPH treatment during the study period
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients eligible for Pulmonary endarterectomy
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Mortality due to CTEPH and CTEPH related complications
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of healthcare professional visits due to CTEPH and CTEPH related complications
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • The total number of days of hospitalization due to CTEPH and CTEPH related complications
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients eligible for Balloon Pulmonary Angioplasty
    date_rangeTime Frame:
    Up to 3 years

Trial design

EMEA CTEPH Registry: An international prospective registry investigating the epidemiology, diagnosis and treatment of CTEPH patients in EMEA countries
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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