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Идёт набор NCT07375433

Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis

— Наблюдательное COPD (Chronic Obstructive Pulmonary Disease) Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Echocardiography, Spirometry, Body plethysmography, 6-Minute Walk Test (6MWT).
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis). Базовые параметры: 50 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.

Подробное описание

Study aim of Investigation "Heart Failure with Preserved Ejection Fraction in Patients with Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis" (HIPSTER) is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.

It is assumed that newly diagnosed HFpEF will occur in at least 6% (COPD PRIORITY data) of cases, and, the presence of HFpEF will negatively affect both the manifestations of the disease and the outcomes and prognosis

During the study it is planned to:

1. Perform a retrospective analysis of patient records, determine the frequency of intracardiac hemodynamic disorders, corresponding with the criteria for HFpEF and compare them with the diagnosis in clinical records. 2. Identify the patients with previously undiagnosed HFpEF among patients with COPD, and evaluate the frequency of cardiorespiratory comorbidity. 3. Examine the general clinical and biochemical blood test parameters in the study groups (as part of a routine in-patient examination). 4. Evaluate echocardiography parameters in the study groups (as part of a routine protocol + epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension (EDD). 5. Compare spirometry and body plethysmography parameters in the groups depending on the presence of HFpEF criteria. 6. Compare the functional status (Six-Minute Walk Test, 6MWT) in the study groups. 7. Evaluate patient's vital status after 12 months, information about hospitalizations and their reasons.

Вмешательства

  • Диагностический тест Echocardiography
    Transthoracic echocardiography at rest: with determination of epicardial fat tissue thickness, epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension
  • Диагностический тест Spirometry
    Spirometry is the most common of the pulmonary function tests, which measures the lung capacity and airway patency (volume and speed of air) during quiet and forced breathing.
  • Диагностический тест Body plethysmography
    Body plethysmography is a non-invasive lung function test performed in a sealed booth (body box) that measures total lung volume, functional residual capacity, and airway resistance by using Boyle's Law to track pressure and volume changes as a patient breathes, providing crucial data for diagnosing conditions like COPD and asthma, and differentiating them from other lung disorders
  • Диагностический тест 6-Minute Walk Test (6MWT)
    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
  • Диагностический тест laboratory biomarker analysis
    Routine and special laboratory tests

Первичные конечные точки

  • Primary composite endpoin [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Verified diagnosis of COPD;
  • Patients hospitalized with COPD;
  • Citizenship of the Russian Federation;
  • Patients aged 50 to 70 years;
  • Patient consent to participate in the study.

Критерии исключения

  • Lack of Russian Federaion citizenship;
  • Patient's refusal to participate in the study;
  • Any chronic diseases, other than COPD, that affect the prognosis, in the acute and/or decompensated stage;
  • Mental disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Россия · 2 центра
  • Kazan State Medical University — Kazan'
  • National Medical Research Center for Therapy and Preventive Medicine — Moscow

Идентификаторы

NCT: NCT07375433 · 06-08/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗