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

Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe

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

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure
• Intervention / Treatment: Procedure: Clinical examination centered on congestion; Procedure: Cardio-pulmonary and peritoneal ultrasound; Biological: Blood sample retrieved for biological assessment and biobanking; Other: Telephone interview; Biological: Urinary sample retrieved for biological assessment and biobanking; Procedure: jugular and renal ultrasound (optional)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas GIRERD, MD,PhD; Phone Number: + 33 3 + 33 3 83 15 74 96; Email: n.girerd@chru-nancy.fr

Study Locations

• France
  • Lorraine
    • Metz, Lorraine, France, 57000
      • Recruiting
      • CHR Metz-Thionville - Hôpital de Mercy
      • Principal Investigator: Noura ZANNAD, MD
    • Vandœuvre-lès-Nancy, Lorraine, France, 54500
      • Recruiting
      • CHRU Nancy Hôpitaux de Brabois
      • Principal Investigator: Nicolas GIRERD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 18 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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, 12 and 24 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; Procedure: jugular and renal ultrasound (optional); optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause death	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 the day hospitalization (with outcome 2 and 3)	at 3 months after hospital discharge
Rate of rehospitalization for acute heart failure	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 the day hospitalization (with outcome 1 and 3)	at 3 months after hospital discharge
Rate of day-hospital or at-home IV diuretics injection for acute HF	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 the day hospitalization (with outcome 1 and 2)	at 3 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical congestion markers as assessed with the Ambrosy Score	Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Clinical congestion markers as assessed with the ASCEND score	Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Natriuretic peptides	Natriuretic peptides at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Estimated plasma volume	Estimated plasma volume at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Ultrasound congestion markers	B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion	at admission and at final discharge (an average of 10 days after admission)
Residual congestion	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%	at final discharge (an average of 10 days after admission)
NYHA class	NYHA class (1, 2, 3, 4)	3 months after hospital discharge
Rate of day-hospital for Intravenous diuretics administration for acute HF	To identify the markers of congestion (clinical, biological, and ultrasonographic), at the end of hospitalization for ICA most strongly associated with the risk of intravenous administration of diuretics in day-hospital for ICA at 3,12, and 24 months after hospital discharge.	3, 12 and 24 months after hospitalization
Rate of all-cause death	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 12 and 13)	12 and 24 months after hospitalization
Rate of hospitalization for acute heart failure	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 13)	12 and 24 months after hospitalization
Rate of day-hospital or in-home IV diuretics injection for acute HF	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)	12 and 24 months after hospitalization

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nicolas GIRERD, MD,PhD, Centre d'Investigation Clinique 1433 module Plurithématique de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Acute Heart Failure; Congestion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2017-A01455-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No