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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02637050
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date December 4, 2015
First Posted Date December 22, 2015
Last Update Posted Date July 3, 2019
Actual Study Start Date March 3, 2016
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2015)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02637050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 11, 2018)
  • 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.
  • Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy [ Time Frame: Up to 3 years ]
    Not yet assessable/Recurrent/Residual
  • Time span between onset of symptoms and CTEPH diagnosis [ Time Frame: Up to 3 years ]
  • Usage of diagnostic tools of CTEPH patients (Y/N) [ Time Frame: Up to 3 years ]
  • 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 ]
  • 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 ]
  • Changes in CTEPH treatment during the study period [ Time Frame: Up to 3 years ]
  • Number of patients eligible for Pulmonary endarterectomy [ Time Frame: Up to 3 years ]
  • NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels [ Time Frame: Up to 3 years ]
  • Mortality due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  • Number of healthcare professional visits due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  • The total number of days of hospitalization due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  • Number of patients eligible for Balloon Pulmonary Angioplasty [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures
 (submitted: December 18, 2015)
  • Rate of operable to inoperable subtypes [ Time Frame: Up to 3 years ]
  • Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy [ Time Frame: Up to 3 years ]
  • Time span between onset of symptoms and CTEPH diagnosis [ Time Frame: Up to 3 years ]
  • Usage of diagnostic tools of CTEPH patients (Y/N) [ Time Frame: Up to 3 years ]
  • 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 ]
  • 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 ]
  • Changes in CTEPH treatment during the study period [ Time Frame: Up to 3 years ]
  • Number of patients eligible for Pulmonary endarterectomy [ Time Frame: Up to 3 years ]
  • NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels [ Time Frame: Up to 3 years ]
  • Mortality due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  • Number of healthcare professional visits due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
  • The total number of days of hospitalization due to CTEPH and CTEPH related complications [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
Condition Hypertension, Pulmonary
Intervention Other: Standard of care
At the discretion of the attending physician.
Study Groups/Cohorts CTEPH Patients
Patients with confirmed diagnosis of CTEPH
Intervention: Other: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 24, 2017)
231
Original Estimated Enrollment
 (submitted: December 18, 2015)
200
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan,   Kyrgyzstan,   Lebanon,   Russian Federation,   Saudi Arabia,   Turkey
Removed Location Countries Algeria,   United Arab Emirates
 
Administrative Information
NCT Number NCT02637050
Other Study ID Numbers 18303
AD 1502 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2019