Acute Heart Failure – COngestion Discharge Evaluation

Overview

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.

Full Title of Study: “Acute Heart Failure – COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d’Hospitalisation Pour Insuffisance Cardiaque aiguë.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 20, 2026

Interventions

  • Procedure: Clinical examination centered on congestion
    • Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital
  • Procedure: 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
  • Procedure: Blood sample retrieved for biological assessment and biobanking
    • Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital
  • Procedure: Telephone follow-up
    • Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital
  • Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Questionnaire centered on patient’s quality of life at discharge and 3, 12 and 24 months after discharge

Arms, Groups and Cohorts

  • Experimental: Patients hospitalized for acute heart failure
    • Patients hospitalized for acute heart failure will undergo the following evaluations: Clinical examination focusing on congestion Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds Blood sample retrieved for biological assessment and biobanking Telephone follow-up

Clinical Trial Outcome Measures

Primary Measures

  • Rate of all-cause death
    • Time Frame: 3 months after hospital discharge
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)
  • Rate of re-hospitalisation for acute heart failure
    • Time Frame: 3 months after hospital discharge
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)
  • Rate of day-hospital or in-home IV diuretics injection for acute HF
    • Time Frame: 3 months after hospital discharge
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)

Secondary Measures

  • Rate of all-cause death
    • Time Frame: 3, 12 and 24 months after hospital discharge
  • Rate of re-hospitalisation for acute heart failure
    • Time Frame: 3,12 and 24 months after hospital discharge
  • Rate of day-hospital or in-home IV diuretics injection for acute HF
    • Time Frame: 3,12 and 24 months after hospital discharge
  • Rate of all-cause death
    • Time Frame: 12 and 24 months after hospital discharge
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 8 and 9)
  • Rate of re-hospitalisation for acute heart failure
    • Time Frame: 12 and 24 months after hospital discharge
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 9)
  • Rate of day-hospital or in-home IV diuretics injection for acute HF
    • Time Frame: 12 and 24 months after hospital discharge.
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 8)
  • Rate of all-cause death
    • Time Frame: 3, 12 and 24 months after hospital discharge.
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 12)
  • Rate of hospitalization for acute heart failure
    • Time Frame: 3, 12 and 24 months after hospital discharge.
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 12)
  • Rate of day-hospital or in-home IV diuretics injection for acute HF
    • Time Frame: 3, 12 and 24 months after hospital discharge.
    • composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 11)
  • NYHA (New York Heart Association) class measured
    • Time Frame: 3, 12 and 24 months after hospital discharge
  • Natriuretic peptides
    • Time Frame: within 24 months after hospital discharge.
    • BNP or Nt-Pro BNP
  • Renal function assessed by glomerular filtration rate
    • Time Frame: within 24 months after hospital discharge.
  • Plasma volume
    • Time Frame: within 24 months after hospital discharge.
    • calculated from haemoglobin and haematocrit value
  • Liver elastography value
    • Time Frame: At inclusion
    • Measured with Fibroscan
  • Quality of life
    • Time Frame: At inclusion and 3, 6 and 24 months
    • Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pr. Nicolas GIRERD, Principal Investigator – Central Hospital, Nancy, France
  • Overall Official(s)
    • Nicolas GIRERD, MD,PhD, Principal Investigator, CHRU of Nancy
  • Overall Contact(s)
    • Nicolas GIRERD, MD,PhD, + 33 3 83 15 73 22, n.girerd@chru-nancy.fr

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