Clinical trial NCT03327532: Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
Official title: Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Heart Failure
Keywords: Acute Heart Failure
Congestion
Ultrasound
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of all-cause death
timeFrame: at 3 months after hospital discharge
measure: Rate of rehospitalization for acute heart failure
timeFrame: at 3 months after hospital discharge
measure: Rate of day-hospital or at-home IV diuretics injection for acute HF
timeFrame: at 3 months after hospital discharge
Secondary outcomes:
measure: Clinical congestion markers as assessed with the Ambrosy Score
timeFrame: at admission and at final discharge (an average of 10 days after admission)
measure: Clinical congestion markers as assessed with the ASCEND score
timeFrame: at admission and at final discharge (an average of 10 days after admission)
measure: Natriuretic peptides
timeFrame: at admission and at final discharge (an average of 10 days after admission)
measure: Estimated plasma volume
timeFrame: at admission and at final discharge (an average of 10 days after admission)
measure: Ultrasound congestion markers
timeFrame: at admission and at final discharge (an average of 10 days after admission)
measure: Residual congestion
timeFrame: at final discharge (an average of 10 days after admission)
measure: NYHA class
timeFrame: 3 months after hospital discharge
measure: Rate of day-hospital for Intravenous diuretics administration for acute HF
timeFrame: 3, 12 and 24 months after hospitalization
measure: Rate of all-cause death
timeFrame: 12 and 24 months after hospitalization
measure: Rate of hospitalization for acute heart failure
timeFrame: 12 and 24 months after hospitalization
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 12 and 24 months after hospitalization
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville - Hôpital de Mercy
state: Lorraine
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy Hôpitaux de Brabois
state: Lorraine
Study officials:
affiliation: Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
name: Nicolas GIRERD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: