Clinical trial

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

Name
2017-A01455-48
Description
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 arms
Trial start
2018-02-13
Estimated PCD
2024-05-01
Trial end
2026-02-01
Status
Recruiting
Treatment
Clinical examination centered on congestion
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
Arms:
Patients hospitalized for acute heart failure
Cardio-pulmonary and peritoneal ultrasound
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
Arms:
Patients hospitalized for acute heart failure
Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
Arms:
Patients hospitalized for acute heart failure
Telephone interview
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
Arms:
Patients hospitalized for acute heart failure
Urinary sample retrieved for biological assessment and biobanking
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
Arms:
Patients hospitalized for acute heart failure
jugular and renal ultrasound (optional)
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital
Arms:
Patients hospitalized for acute heart failure
Size
80
Primary endpoint
Rate of all-cause death
at 3 months after hospital discharge
Rate of rehospitalization for acute heart failure
at 3 months after hospital discharge
Rate of day-hospital or at-home IV diuretics injection for acute HF
at 3 months after hospital discharge
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-08-31

1 organization

2 products

1 indication

Organization
Central Hospital