Идёт набор NCT04343443
Acute Heart Failure With Reduced Ejection Fraction - 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, Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Biological: Blood sample retrieved for biological assessment and biobanking, Telephone interview.
- 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 With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection altérée ou modérément altérée
Обзор
The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure. The main objective of the AHF-CODE study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
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 Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital - Процедура Biological: Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed before discharge from hospital - Процедура Telephone interview
Telephone interview will be performed at 3, 12 months 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 IV diuretics injection for acute HF [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Rate of all-cause death [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Rate of hospitalisation for acute heart failure [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Rate of all-cause death [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Rate of hospitalisation for acute heart failure [Срок оценки: 3, 12 and 24 months after hospital discharge]
- NYHA (New York Heart Association) class [Срок оценки: 3, 12 and 24 months after hospital discharge]
- Natriuretic peptides [Срок оценки: At inclusion]
- Renal function assessed by glomerular filtration rate [Срок оценки: At inclusion]
- Plasma volume [Срок оценки: At inclusion]
- Blood potassium [Срок оценки: At inclusion]
Критерии участия
Критерии включения
- Patients hospitalised for acute heart failure.
- Patients with reduced ejection fraction (Ejection Fraction <40%) or (40% ≤ Ejection Fraction < 50)
- 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: NCT04343443 · 2019PI188-3