Registry of Patients With chrOnic thromboemboLic Pulmonary hypErTension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary endarterectomy, Balloon pulmonary angioplasty, Pulmonary hypertension-specific therapy.
- Who it may be relevant to
- Registry conditions: Chronic Thromboembolic Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Russia: Determinants of Long-term Outcomes in Real Clinical Practice
Overview
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.
Interventions
- Procedure Pulmonary endarterectomy
A surgical procedure to remove chronic blood clots from the pulmonary arteries - 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 - Drug Pulmonary hypertension-specific therapy
Medical treatment with any PH-specific drugs
Primary outcome measures
- All-cause mortality [Time frame: Up to 5 years]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Presence of a confirmed diagnosis of CTEPH
Exclusion criteria
- Presence of pulmonary hypertension of a different etiology than CTEPH
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- National Medical Research Center of Cardiology after academician E.I. Chazov — Moscow
Identifiers
NCT: NCT07254078 · 313