Registry of Patients With chrOnic thromboemboLic Pulmonary hypErTension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2035-05-01

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Pulmonary endarterectomy

A surgical procedure to remove chronic blood clots from the pulmonary arteries

Intervention Type PROCEDURE

Balloon pulmonary angioplasty

A minimally invasive procedure used to treat chronic thromboembolic pulmonary hypertension by dilatating narrowed pulmonary arteries and improving blood flow to the lungs

Intervention Type PROCEDURE

Pulmonary hypertension-specific therapy

Medical treatment with any PH-specific drugs

Intervention Type DRUG

Other Intervention Names

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PEA PTE Pulmonary thromboendarterectomy BPA PH-specific therapy PH-Targeted Medical Therapy

Eligibility Criteria

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Inclusion Criteria

* Presence of a confirmed diagnosis of CTEPH

Exclusion Criteria

* Presence of pulmonary hypertension of a different etiology than CTEPH

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Irina E. Chazova

D. Sci. (Med.), Acad. RAS, Prof., Deputy Director General for Scientific and Expert Work, FSBI NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV of the Ministry of Health of the Russian Federation

Responsibility Role SPONSOR_INVESTIGATOR