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Идёт набор NCT06683001

National Heart Failure Registry

— Наблюдательное Chronic Heart Failure

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Heart Failure. Базовые параметры: от 18 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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Официальное название

CHaracterization Of the STate of the System of Care for Patients With Chronic Heart Failure in the Regions of the Russian Federation: Identification, Diagnostics, Treatment, Observation

Обзор

A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation. The study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination. A control observation group is not intended.

Подробное описание

The study will include retrospective and prospective data of patients with an outpatient or inpatient diagnosis of CHF.

The duration of the observation period of an individual patient with CHF is limited by the study period, or the patient's death, and includes the studied retrospective and dynamic prospective parameters. Prospective data of CHF (any stage and FC) subjects are planned to be included sequentially as they appear in inpatient CHF centers and outpatient CHF offices until 12/31/2027 inclusive and further upon extension of the study.

Retrospective data will be provided by chief freelance cardiologists of 33 constituent entities of the Russian Federation (Central Federal District, Ural Federal District, Siberian Federal District, Far Eastern Federal District) (individually, according to agreement)

Первичные конечные точки

  • Age of subjects with different phenotypes and stages of CHF [Срок оценки: Every 12 months, up to 3 years]
  • Female to male sex ratio of subjects with different phenotypes and stages of CHF [Срок оценки: Every 12 months, up to 3 years]
  • Clinical status of subjects with different phenotypes and stages of CHF [Срок оценки: Every 12 months, up to 3 years]
  • Proportion of employable and working subjects with different phenotypes and stages of CHF [Срок оценки: Every 12 months, up to 3 years]
  • The proportion of subjects with different algorithms for diagnosing CHF and the proportion of subjects with a verified diagnosis of CHF (established according to the recommended algorithm for diagnosing CHF) [Срок оценки: Every 12 months, up to 3 years]
  • The proportion of subjects taking drugs of each class and all four classes of the recommended four-component therapy regimen (in the overall choice and in different phenotypes of CHF; working/non-working age; working/non-working) [Срок оценки: Every 12 months, up to 3 years]
  • Number and proportion of subjects with wearable devices when using an online tool for identifying subjects with CHF with indications for high-tech medical care [Срок оценки: Every 12 months, up to 3 years]
  • Number and proportion of subjects when using an online tool for identifying subjects with CHF with indications for high-tech medical care [Срок оценки: Every 12 months, up to 3 years]
Вторичные конечные точки (12)
  • Proportions of subjects with an increase in EF ≥10% and a decrease in the functional class of CHF by 1 point [Срок оценки: Every 12 months, up to 3 years]
  • The proportion of subjects hospitalized for decompensated CHF in the departments of therapeutic and cardiology profiles * [Срок оценки: Every 12 months, up to 3 years]
  • Proportion of subjects with newly diagnosed type 2 diabetes* [Срок оценки: Every 12 months]
  • Proportion of subjects with deterioration of renal function* [Срок оценки: Every 12 months, up to 3 years]
  • Proportion of subjects with newly diagnosed malignant neoplasm* [Срок оценки: Every 12 months, up to 3 years]
  • Proportion of subjects who died from CV causes* [Срок оценки: Every 12 months, up to 3 years]
  • Proportion of subjects with different causes of death* [Срок оценки: Every 12 months, up to 3 years]
  • Incidence and event rates (per 100 subject-years) for hospitalizations due to HF* [Срок оценки: Every 12 months, up to 3 years]
  • Incidence and event rates (per 100 subject-years) for death from CV causes* [Срок оценки: Every 12 months, up to 3 years]
  • Incidence and event rates (per 100 subject-years) for death from any cause* [Срок оценки: Every 12 months, up to 3 years]
  • The proportion of subjects with preferential drug provision for cardiovascular disease, diabetes mellitus* [Срок оценки: Every 12 months, up to 3 years]
  • Average frequency of outpatient visits of subjects with CHF to medical institutions* [Срок оценки: Every 12 months, up to 3 years]

Критерии участия

Критерии включения

  • Any stage and/or any class of CHF

Критерии исключения

  • Subjects whose source records cant be obtained for the analysis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Россия · 1 центр
  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation — Moscow

Идентификаторы

NCT: NCT06683001 · HOSTa CHF · ХОСТА ХСН

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗