Registry of Patients With chrOnic thromboemboLic Pulmonary hypErTension (POLET)

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?

Study Overview

• Status: Recruiting
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Procedure: Pulmonary endarterectomy; Procedure: Balloon pulmonary angioplasty; Drug: Pulmonary hypertension-specific therapy

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • National Medical Research Center of Cardiology after academician E.I. Chazov
    • Contact: Galina V Schelkova; Phone Number: +74954146270; Email: GVShchelkova@Cardio.ru
    • Principal Investigator: Irina E Chazova, D. Sci. (Med.)
    • Principal Investigator: Nikolay M Danilov, D. Sci. (Med.)
    • Sub-Investigator: Galina V Schelkova, PhD
    • Sub-Investigator: Sergey Y Yarovoy, PhD
    • Sub-Investigator: Ekaterina O Dinevich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

operable CTEPH, non-operable CTEPH

Description

Inclusion Criteria:

• Presence of a confirmed diagnosis of CTEPH

Exclusion Criteria:

• Presence of pulmonary hypertension of a different etiology than CTEPH

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		Up to 10 years
Change in distance in 6-minute walk test		1 year
Change in mPAP	mPAP assesed during right heart catheterization	1 year

Collaborators and Investigators

• Sponsor: Irina E. Chazova

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Estimated): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: survival; registry; PEA; CTEPH; BPA; PAH-specific therapy
• Other Study ID Numbers: 313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No