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Completed

NCT Number: NCT02637050

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

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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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Kazakhstan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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
  • 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

Treatment and study plan

Standard of care

Other

At the discretion of the attending physician.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries

Acronym: EMEA CTEPH

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2015
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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