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

  • STATUS
    Recruiting
  • End date
    Mar 27, 2022
  • participants needed
    80
  • sponsor
    Central Hospital, Nancy, France
Updated on 27 January 2021
congestion

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

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.

Details
Condition Acute Heart Failure
Treatment Telephone interview, Clinical examination centered on congestion, Cardio-pulmonary and peritoneal ultrasound, Blood sample retrieved for biological assessment and biobanking, Urinary sample retrieved for biological assessment and biobanking
Clinical Study IdentifierNCT03327532
SponsorCentral Hospital, Nancy, France
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
Woman of childbearing age without effective contraception
Suspected cardiac amylose or proven cardiac amylose
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
Exacerbation of heart failure attributed to valvular heart disease
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
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