Hypertension, PulmonaryEMEA CTEPHNCT02637050
A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries
An observational study of Hypertension, Pulmonary, run by Bayer at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- How many people
- 231 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 3 Mar 2016to 17 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Standard of care
- Keywords
- Type IV Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, CTEPH
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
At the discretion of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| CTEPH Patients | Patients with confirmed diagnosis of CTEPH Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to 3 years
Secondary outcomes (13)
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.
Measured: Up to 3 years
Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy
Not yet assessable/Recurrent/Residual
Measured: Up to 3 years
Time span between onset of symptoms and CTEPH diagnosis
Measured: Up to 3 years
Usage of diagnostic tools of CTEPH patients (Y/N)
Measured: 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
Measured: 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
Measured: Up to 3 years
Changes in CTEPH treatment during the study period
Measured: Up to 3 years
Number of patients eligible for Pulmonary endarterectomy
Measured: Up to 3 years
NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels
Measured: Up to 3 years
Mortality due to CTEPH and CTEPH related complications
Measured: Up to 3 years
Number of healthcare professional visits due to CTEPH and CTEPH related complications
Measured: Up to 3 years
The total number of days of hospitalization due to CTEPH and CTEPH related complications
Measured: Up to 3 years
Number of patients eligible for Balloon Pulmonary Angioplasty
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start3 Mar 2016
- Primary completion3 Jul 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637050
- Sponsor's protocol ID
- 18303
- Other IDs
- AD 1502
- Acronym
- EMEA CTEPH
- Status last verified
- Aug 2021
- First submitted
- 4 Dec 2015
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38381283
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
- ClinicalTrials.gov ID
- NCT02637050
- Acronym / sponsor ID
- EMEA CTEPH / 18303
- Conditions
- Hypertension, Pulmonary
- Keywords
- Type IV Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, CTEPH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTEPH Patients | – | Other: Standard of carePatients with confirmed diagnosis of CTEPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CTEPH (Chronic Thromboembolic Pulmonary Hypertension) patients in Expert PH (Pulmonary Hypertension) centers
Key inclusion criteria (10 listed)
- 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):
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careAt the discretion of the attending physician. | Other | CTEPH Patients |
Primary outcome
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)
13 secondary outcomes
Eligibility for PEA
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
Number of patients eligible for Balloon Pulmonary Angioplasty
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 38381283Ongen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by Bayer at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Kazakhstan, Kyrgyzstan, Lebanon, Russia, Saudi Arabia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.