Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
NCT ID: NCT03327532
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2018-02-13
2026-02-28
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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 examination centered on congestion
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
Cardio-pulmonary and peritoneal ultrasound
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
Telephone interview
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
Urinary sample retrieved for biological assessment and biobanking
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
jugular and renal ultrasound (optional)
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital
Interventions
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Clinical examination centered on congestion
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
Cardio-pulmonary and peritoneal ultrasound
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
Telephone interview
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
Urinary sample retrieved for biological assessment and biobanking
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
jugular and renal ultrasound (optional)
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Pr. Nicolas GIRERD
Professor
Principal Investigators
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Nicolas GIRERD, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
Locations
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CHR Metz-Thionville - Hôpital de Mercy
Metz, Lorraine, France
CHRU Nancy Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, France
Countries
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Central Contacts
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Other Identifiers
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2017-A01455-48
Identifier Type: -
Identifier Source: org_study_id
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