Chronic Heart Failure - COngestion eValuation
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: Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography, Blood sample retrieved for biological assessment and biobanking, Telephone follow-up.
- 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
- Франция
- 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
Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)
Обзор
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. The main objective of the CHF-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.
Вмешательства
- Процедура Clinical examination centered on congestion
Clinical examination (including the EVEREST, ASCEND and Ambrosy scores) centered on congestion will be performed during day hospitalization or consultation - Процедура Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional - Процедура Blood sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation - Другое Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after visit (during day hospitalization or consultation) - Поведенческое Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Первичные конечные точки
- Rate of death from all causes [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Срок оценки: 24 months after day hospitalization or consultation]
Вторичные конечные точки (12)
- Rate of death from all causes [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for cardiovascular reason [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of death from all causes [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Срок оценки: 24 months after day hospitalization or consultation]
- Rate of cardiovascular death [Срок оценки: 24 months after day hospitalization or consultation]
- NYHA (New York Heart Association) class measured [Срок оценки: 3, 12 and 24 months after day hospitalization or consulation]
- Natriuretic peptides [Срок оценки: At inclusion]
- Renal function assessed by glomerular filtration rate [Срок оценки: At inclusion]
- Plasma volume [Срок оценки: At inclusion]
- Rate of Bilirubin [Срок оценки: At inclusion]
- Rate of ASAT [Срок оценки: At inclusion]
Критерии участия
Критерии включения
- Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation
- Age ≥18 years
- Patients having received complete information regarding the study design and having signed their informed consent form.
- Patient affiliated to or beneficiary of a social security scheme.
Критерии исключения
- Comorbidity for which the life expectancy is ≤ 3 months
- Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- Pregnant woman, parturient or nursing mother
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- Adult person who is unable to give consent
- Person deprived of liberty by a judicial or administrative decision,
- Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 2 центра
- CHRU de Nancy — Vandœuvre-lès-Nancy
- CHRU de Nancy — Vandœuvre-lès-Nancy
Идентификаторы
NCT: NCT05089149 · 2020PI145-1 · 2020-A02438-31