CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

Официальное название

Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - 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-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.

Вмешательства

• Процедура Clinical examination centered on congestion
  Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
• Процедура Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds
  Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds 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 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]
• Rate of day-hospital or in-home IV diuretics injection for acute HF [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 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 day-hospital or in-home IV diuretics injection for acute HF [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: 3, 12 and 24 months after day hospitalization or consulation]
• 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 consultation]
• Natriuretic peptides [Срок оценки: At inclusion]
• Renal function [Срок оценки: At inclusion]

Критерии участия

Критерии включения

• Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
• Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
• 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: NCT05089162 · 2020PI145-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗