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

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

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Other: Standard of care

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 3 years
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)	Up to 3 years
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)	Up to 3 years
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)	Up to 3 years
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)	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 years
Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy	Not yet assessable/Recurrent/Residual	Up to 3 years
Time span between onset of symptoms and CTEPH diagnosis		Up to 3 years
Usage of diagnostic tools of CTEPH patients (Y/N)		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		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		Up to 3 years
Changes in CTEPH treatment during the study period		Up to 3 years
Number of patients eligible for Pulmonary endarterectomy		Up to 3 years
NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels		Up to 3 years
Mortality due to CTEPH and CTEPH related complications		Up to 3 years
Number of healthcare professional visits due to CTEPH and CTEPH related complications		Up to 3 years
The total number of days of hospitalization due to CTEPH and CTEPH related complications		Up to 3 years
Number of patients eligible for Balloon Pulmonary Angioplasty		Up to 3 years

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): September 17, 2020

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: CTEPH; Chronic Thromboembolic Pulmonary Hypertension; Type IV Pulmonary Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 18303; AD 1502 (Other Identifier: Company Internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No