Chronic Thromboembolic Pulmonary HypertensionPOLETNCT07254078
Registry of Patients With chrOnic thromboemboLic Pulmonary hypErTension
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Irina E. Chazova at 1 site in Russia.
Trial summary
The goal of this observational study is to gather information on background, medical history, symptoms and physical condition, treatment options of people with chronic thromboembolic pulmonary hypertension in real clinical practice in Russia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Pulmonary endarterectomy, Balloon pulmonary angioplasty and Pulmonary hypertension-specific therapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2025to 1 May 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: operable CTEPH, non-operable CTEPH
Who may be able to join
- Presence of a confirmed diagnosis of CTEPH
Who cannot join
- Presence of pulmonary hypertension of a different etiology than CTEPH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center of Cardiology after academician E.I. Chazov
Moscow
Galina V Schelkova, +74954146270, GVShchelkova@Cardio.ru
Irina E Chazova, D. Sci. (Med.)
About this study
Official title: Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Russia: Determinants of Long-term Outcomes in Real Clinical Practice
The goal of this observational study is to gather information on background, medical history, symptoms and physical condition, treatment options of people with chronic thromboembolic pulmonary hypertension in real clinical practice in Russia.
The main question it aims to answer is:
Which factors most influence the prognosis of participants?
Read the detailed description
Data from international CTEPH registries indicate variable utilization rates of available treatment options. Considering the presence of national specificities in the management of CTEPH patients, coupled with the relatively low prevalence of the disease, which poses challenges for data accumulation and research, new registry POLET (Registry of Patients with chrOnic thombomboLic pumonary hypErTension) is established to investigate CTEPH patients in real-world clinical practice.
Registry Aim:
To investigate the prognosis of patients with chronic thromboembolic pulmonary hypertension based on demographic, anamnestic, clinical characteristics, and treatment regimens.
Registry Objectives:
To describe the key demographic, anamnestic, and clinical characteristics of CTEPH patients in Russia.
To identify factors influencing the frequency of hospitalizations due to clinical deterioration in CTEPH patients.
To determine the impact of anamnestic data and treatment regimens on patient prognosis (time to clinical deterioration/death).
To determine the impact of demographic and clinical characteristics on patient survival and prognosis (time to clinical deterioration/death).
Currently, preliminary retrospective data have been collected on 300 CTEPH patients, each with 1 to 15 hospitalizations at the National Medical Research Center of Cardiology named after Academician E.I. Chazov of the Ministry of Health of Russia from 2012-2024, and who are eligible for inclusion in the registry. 200 patients will be enrolled prospectively.
The following data to be extracted from electronic medical records:
Medical History Data; Clinical Characteristics and Results of Investigations and Treatments During Each Patient Hospitalization; Operability Assessment Results; PAH-Specific Therapy, Anticoagulant Therapy, Supportive Therapy: Therapy Adjustment, Doses, Presence of Side Effects; Details of Pulmonary endarterectomy; Details of BPA performed; Patient outcomes including survival. Statistical data processing will be performed using RStudio and the R programming language. Missing data will be handled with imputation approach.
- Being tested
- Pulmonary endarterectomy, Balloon pulmonary angioplasty, Pulmonary hypertension-specific therapy
- Keywords
- CTEPH, registry, PEA, BPA, PAH-specific therapy, survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary endarterectomyProcedure or surgery
Also called PEA, PTE, Pulmonary thromboendarterectomy
A surgical procedure to remove chronic blood clots from the pulmonary arteries
Balloon pulmonary angioplastyProcedure or surgery
Also called BPA
A minimally invasive procedure used to treat chronic thromboembolic pulmonary hypertension by dilatating narrowed pulmonary arteries and improving blood flow to the lungs
Pulmonary hypertension-specific therapyDrug
Also called PH-specific therapy, PH-Targeted Medical Therapy
Medical treatment with any PH-specific drugs
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Up to 5 years
Secondary outcomes (3)
All-cause mortality
Measured: Up to 10 years
Change in distance in 6-minute walk test
Measured: 1 year
Change in mPAP
mPAP assesed during right heart catheterization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 May 2025
- Primary completion1 May 2035 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Irina E. Chazova
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Irina E. Chazova, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254078
- Sponsor's protocol ID
- 313
- Acronym
- POLET
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Russia: Determinants of Long-term Outcomes in Real Clinical Practice
- ClinicalTrials.gov ID
- NCT07254078
- Acronym / sponsor ID
- POLET / 313
- Keywords
- CTEPH, registry, PEA, BPA, PAH-specific therapy, survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Irina E. ChazovaOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2035 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 28 Nov 2025 (actual)
- 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 goal of this observational study is to gather information on background, medical history, symptoms and physical condition, treatment options of people with chronic thromboembolic pulmonary hypertension in real clinical practice in Russia.
The main question it aims to answer is:
Which factors most influence the prognosis of participants?
Detailed description
Data from international CTEPH registries indicate variable utilization rates of available treatment options. Considering the presence of national specificities in the management of CTEPH patients, coupled with the relatively low prevalence of the disease, which poses challenges for data accumulation and research, new registry POLET (Registry of Patients with chrOnic thombomboLic pumonary hypErTension) is established to investigate CTEPH patients in real-world clinical practice.
Registry Aim:
To investigate the prognosis of patients with chronic thromboembolic pulmonary hypertension based on demographic, anamnestic, clinical characteristics, and treatment regimens.
Registry Objectives:
To describe the key demographic, anamnestic, and clinical characteristics of CTEPH patients in Russia.
To identify factors influencing the frequency of hospitalizations due to clinical deterioration in CTEPH patients.
To determine the impact of anamnestic data and treatment regimens on patient prognosis (time to clinical deterioration/death).
To determine the impact of demographic and clinical characteristics on patient survival and prognosis (time to clinical deterioration/death).
Currently, preliminary retrospective data have been collected on 300 CTEPH patients, each with 1 to 15 hospitalizations at the National Medical Research Center of Cardiology named after Academician E.I. Chazov of the Ministry of Health of Russia from 2012-2024, and who are eligible for inclusion in the registry. 200 patients will be enrolled prospectively.
The following data to be extracted from electronic medical records:
Medical History Data; Clinical Characteristics and Results of Investigations and Treatments During Each Patient Hospitalization; Operability Assessment Results; PAH-Specific Therapy, Anticoagulant Therapy, Supportive Therapy: Therapy Adjustment, Doses, Presence of Side Effects; Details of Pulmonary endarterectomy; Details of BPA performed; Patient outcomes including survival. Statistical data processing will be performed using RStudio and the R programming language. Missing data will be handled with imputation approach.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- operable CTEPH, non-operable CTEPH
Key inclusion criteria (1 listed)
- Presence of a confirmed diagnosis of CTEPH
Key exclusion criteria (1 listed)
- Presence of pulmonary hypertension of a different etiology than CTEPH
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 |
|---|---|---|
| Pulmonary endarterectomyAlso: PEA, PTE, Pulmonary thromboendarterectomyA surgical procedure to remove chronic blood clots from the pulmonary arteries | Procedure or surgery | – |
| Balloon pulmonary angioplastyAlso: BPAA minimally invasive procedure used to treat chronic thromboembolic pulmonary hypertension by dilatating narrowed pulmonary arteries and improving blood flow to the lungs | Procedure or surgery | – |
| Pulmonary hypertension-specific therapyAlso: PH-specific therapy, PH-Targeted Medical TherapyMedical treatment with any PH-specific drugs | Drug | – |
Primary outcome
All-cause mortality
Time frame: Up to 5 years
3 secondary outcomes
All-cause mortality
Time frame: Up to 10 years
Change in distance in 6-minute walk test
Time frame: 1 year
Change in mPAP
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
National Medical Research Center of Cardiology after academician E.I. Chazov
Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Irina E. Chazova at 1 site in Russia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.