Acute Heart Failure - COngestion Discharge 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: Acute 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
Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Обзор
Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound . Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.
Вмешательства
- Процедура Clinical examination centered on congestion
Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital - Процедура Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital - Процедура Blood sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital - Процедура Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital - 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 all-cause death [Срок оценки: 3 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [Срок оценки: 3 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Срок оценки: 3 months after hospital discharge]
Вторичные конечные точки (12)
- Rate of all-cause death [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [Срок оценки: 3,12 and 24 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Срок оценки: 3,12 and 24 months after hospital discharge]
- Rate of all-cause death [Срок оценки: 12 and 24 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [Срок оценки: 12 and 24 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Срок оценки: 12 and 24 months after hospital discharge.]
- Rate of all-cause death [Срок оценки: 3, 12 and 24 months after hospital discharge.]
- Rate of hospitalization for acute heart failure [Срок оценки: 3, 12 and 24 months after hospital discharge.]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Срок оценки: 3, 12 and 24 months after hospital discharge.]
- NYHA (New York Heart Association) class measured [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Natriuretic peptides [Срок оценки: within 24 months after hospital discharge.]
- Renal function assessed by glomerular filtration rate [Срок оценки: within 24 months after hospital discharge.]
Критерии участия
Критерии включения
- Patients hospitalised for acute heart failure.
- Patients considered clinically discharging from hospitalisation for acute heart failure.
- 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 · 1 центр
- CHRU de Nancy — Vandœuvre-lès-Nancy
Идентификаторы
NCT: NCT04332692 · 2019-A03311-56