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

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ClinicalTrials.gov Identifier: NCT02637050
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Other: Standard of care

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Study Type : Observational
Actual Enrollment : 231 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
Actual Study Start Date : March 3, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020


Group/Cohort Intervention/treatment
CTEPH Patients
Patients with confirmed diagnosis of CTEPH
Other: Standard of care
At the discretion of the attending physician.




Primary Outcome Measures :
  1. The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit [ Time Frame: Up to 3 years ]
    6MWD (6 Minutes Walking Distance)

  2. 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 [ Time Frame: Up to 3 years ]
    WHO Functional class (World Health Organization Functional Class)

  3. The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit [ Time Frame: Up to 3 years ]
    PVR (Pulmonary Vascular Resistance)

  4. The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit [ Time Frame: Up to 3 years ]
    CI (Cardiac Index)

  5. The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit [ Time Frame: Up to 3 years ]
    mPAP (mean Pulmonary Arterial Pressure)


Secondary Outcome Measures :
  1. Eligibility for PEA [ Time Frame: Up to 3 years ]
    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.

  2. Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy [ Time Frame: Up to 3 years ]
    Not yet assessable/Recurrent/Residual

  3. Time span between onset of symptoms and CTEPH diagnosis [ Time Frame: Up to 3 years ]
  4. Usage of diagnostic tools of CTEPH patients (Y/N) [ Time Frame: Up to 3 years ]
  5. Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit [ Time Frame: Up to 3 years ]
  6. Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit [ Time Frame: Up to 3 years ]
  7. Changes in CTEPH treatment during the study period [ Time Frame: Up to 3 years ]
  8. Number of patients eligible for Pulmonary endarterectomy [ Time Frame: Up to 3 years ]
  9. NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels [ Time Frame: Up to 3 years ]
  10. Mortality due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  11. Number of healthcare professional visits due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  12. The total number of days of hospitalization due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  13. Number of patients eligible for Balloon Pulmonary Angioplasty [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637050


Locations
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Kazakhstan
Multiple Locations, Kazakhstan
Kyrgyzstan
Multiple Locations, Kyrgyzstan
Lebanon
Multiple Locations, Lebanon
Russian Federation
Multiple Locations, Russian Federation
Saudi Arabia
Multiple Locations, Saudi Arabia
Turkey
Multiple Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02637050     History of Changes
Other Study ID Numbers: 18303
AD 1502 ( Other Identifier: Company Internal )
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Type IV Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
CTEPH

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases