NCT03327532

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6.2 years

First QC Date

September 6, 2017

Last Update Submit

August 30, 2023

Conditions

Acute Heart Failure

Keywords

Acute Heart FailureCongestionUltrasound

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Clinical congestion markers as assessed with the Ambrosy Score

    at admission and at final discharge (an average of 10 days after admission)

  • Clinical congestion markers as assessed with the ASCEND score

    at admission and at final discharge (an average of 10 days after admission)

  • Natriuretic peptides

    at admission and at final discharge (an average of 10 days after admission)

  • Estimated plasma volume

    at admission and at final discharge (an average of 10 days after admission)

  • Ultrasound congestion markers

    at admission and at final discharge (an average of 10 days after admission)

  • +6 more secondary outcomes

Study Arms (1)

Patients hospitalized for acute heart failure

EXPERIMENTAL

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 congestionProcedure: Cardio-pulmonary and peritoneal ultrasoundBiological: Blood sample retrieved for biological assessment and biobankingOther: Telephone interviewBiological: Urinary sample retrieved for biological assessment and biobankingProcedure: jugular and renal ultrasound (optional)

Interventions

Clinical examination centered on congestionPROCEDURE

Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital

Patients hospitalized for acute heart failure
Cardio-pulmonary and peritoneal ultrasoundPROCEDURE

Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital

Patients hospitalized for acute heart failure
Blood sample retrieved for biological assessment and biobankingBIOLOGICAL

Blood sample collection will be performed within 72 hours of admission and before discharge from hospital

Patients hospitalized for acute heart failure
Telephone interviewOTHER

Telephone interview will be performed 3, 12 and 24 months after discharge from hospital

Patients hospitalized for acute heart failure
Urinary sample retrieved for biological assessment and biobankingBIOLOGICAL

Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital

Patients hospitalized for acute heart failure
jugular and renal ultrasound (optional)PROCEDURE

optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital

Patients hospitalized for acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Comorbidity for which life expectancy is ≤ 3 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHR Metz-Thionville - Hôpital de Mercy

Metz, Lorraine, 57000, France

RECRUITING

CHRU Nancy Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nicolas GIRERD, MD,PhD

    Centre d'Investigation Clinique 1433 module Plurithématique de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GIRERD, MD,PhD

CONTACT

+ 33 3 83 15 74 96n.girerd@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2017

First Posted

October 31, 2017

Study Start

February 13, 2018

Primary Completion

May 1, 2024

Study Completion

February 1, 2026

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)