Acute Heart Failure – COngestion Repeated Evaluation (AHF-CORE)

Overview

The AHF-CORE study is a prospective, non-randomized, multicenter regional study. The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge. Secondary objectives are: – Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure. – Assess the correlation between changes in congestion markers between the beginning and end of hospitalization. – Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization. – Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge. – Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge

Full Title of Study: “Acute Heart Failure – COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d’Une Hospitalisation Pour Insuffisance Cardiaque aigüe”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

Detailed Description

Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge. Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected. Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.

Interventions

  • Procedure: Clinical examination centered on congestion
    • Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
  • Procedure: Cardio-pulmonary and peritoneal ultrasound
    • Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
  • Biological: Blood sample retrieved for biological assessment and biobanking
    • Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
  • Other: Telephone interview
    • Telephone interview will be performed 3 months after discharge from hospital
  • Biological: Urinary sample retrieved for biological assessment and biobanking
    • Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital

Arms, Groups and Cohorts

  • Experimental: Patients hospitalized for acute heart failure
    • One arm study. Patients hospitalized for acute heart failure will undergo the following evaluations: Clinical examination centered on congestion Cardiopulmonary and peritoneal ultrasound Blood sample retrieved for biological assessment and biobanking Telephone interview

Clinical Trial Outcome Measures

Primary Measures

  • All-cause mortality
    • Time Frame: at 3 months after hospital discharge
    • composite criteria
  • Rehospitalization for acute heart failure
    • Time Frame: at 3 months after hospital discharge
    • composite criteria

Secondary Measures

  • Clinical congestion markers as assessed with the Ambrosy Score
    • Time Frame: at admission and at final discharge (an average of 10 days after admission)
    • Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge
  • Natriuretic peptides
    • Time Frame: at admission and at final discharge (an average of 10 days after admission)
    • Natriuretic peptides at admission and at final discharge
  • Estimated plasma volume
    • Time Frame: at admission and at final discharge (an average of 10 days after admission)
    • Estimated plasma volume at admission and at final discharge
  • Ultrasound congestion markers
    • Time Frame: at admission and at final discharge (an average of 10 days after admission)
    • B lines, pleural effusion, E/e’, DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion
  • Residual congestion
    • Time Frame: at final discharge (an average of 10 days after admission)
    • as defined as an Ambrosy score 3 or more and/or B-lines score 30 or more and/or an IVC>21 and IVC collapse with sniff <50%
  • NYHA class
    • Time Frame: 3 months after hospital discharge
    • NYHA class (1, 2, 3, 4)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital – Patients over 60 years old – Person affiliated to or beneficiary of a social security plan – Person informed about study organization and having signed the informed consent Exclusion Criteria:

  • Comorbidity for which life expectancy is ≤ 3 months – Diagnosis of heart failure made less than 3 months prior to inclusion – Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation) – Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline – History of pulmonary lobectomy or pneumonectomy – Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis – Suspected cardiac amylose or proven cardiac amylose – Exacerbation of heart failure attributed to valvular heart disease – Woman of childbearing age without effective contraception – Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection. – Persons deprived of liberty for judicial or administrative decision – Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Gender Eligibility: All

Minimum Age: 60 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, Professor – Central Hospital, Nancy, France
  • Overall Official(s)
    • Nicolas GIRERD, MD,PhD, Principal Investigator, Centre d’Investigation Clinique 1433 module Plurithématique de Nancy
  • Overall Contact(s)
    • Nicolas GIRERD, MD,PhD, + 33 3 83 15 74 96, n.girerd@chru-nancy.fr

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