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

NCT02637050 | Completed

• 2 other identifiers: 18303AD 1502
• Study Type: observational
• Target: 231
• Locations: 6 countries
• Sites: 6

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.

Conditions

Hypertension, Pulmonary

Keywords

Type IV Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension; CTEPH

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Eligibility for PEA

  Up to 3 years

• Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy

  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

Study Arms (1)

CTEPH Patients

Patients with confirmed diagnosis of CTEPH

Other: Standard of care

Interventions

Standard of care OTHER

At the discretion of the attending physician.

CTEPH Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Unknown Facility

Multiple Locations, Kazakhstan

Location

Unknown Facility

Multiple Locations, Kyrgyzstan

Location

Unknown Facility

Multiple Locations, Lebanon

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Saudi Arabia

Location

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

Related Publications (1)

• Ongen HG, Akdeniz B, Duzenli MA, Chernyavsky A, Dabar G, Idrees M, Khludeeva E, Kultursay H, Lukianchikova V, Martynyuk T, Mogulkoc N, Mukarov MA, Mutlu B, Okumus G, Omarov A, Onen ZP, Sakkijha H, Shostak N, Simakova M, Tokgozoglu L, Tomskaya T, Yildirim H, Zateyshchikov D, Hechenbichler K, Kessner S, Schauerte I, Turgut N, Vogtlander K, Aldalaan A; CTEPH EMEA Registry Investigators. Diagnosis and Treatment Patterns of Chronic Thromboembolic Pulmonary Hypertension in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia: A Registry Study. Drugs Real World Outcomes. 2024 Mar;11(1):149-165. doi: 10.1007/s40801-023-00407-w. Epub 2024 Feb 21.

  PMID: 38381283 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 22, 2015
• Study Start: March 3, 2016
• Primary Completion: July 3, 2020
• Study Completion: September 17, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

TU (1); KA (1); KY (1); SA (1); LE (1); RU (1)