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

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Other: Standard of care

• Registration Number: NCT02637050
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-22
• Study Start: 2016-03-03
• Primary Completion: 2020-07-03
• Study Completion: 2020-09-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CTEPH Patients	Standard of care	Patients with confirmed diagnosis of CTEPH

Primary Outcome Measures

Name	Time	Method
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit	Up to 3 years	mPAP (mean Pulmonary Arterial Pressure)
The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit	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	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 Cardiac Index (CI) between initial and final visit	Up to 3 years	CI (Cardiac Index)
The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit	Up to 3 years	PVR (Pulmonary Vascular Resistance)

Secondary Outcome Measures

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