Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
- Conditions
- Acute Heart Failure
- Interventions
- 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)
- Registration Number
- NCT03327532
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients hospitalized for acute heart failure Urinary sample retrieved for biological assessment and biobanking 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 Patients hospitalized for acute heart failure Blood sample retrieved for biological assessment and biobanking 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 Patients hospitalized for acute heart failure Clinical examination centered on congestion 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 Patients hospitalized for acute heart failure Cardio-pulmonary and peritoneal ultrasound 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 Patients hospitalized for acute heart failure Telephone interview 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 Patients hospitalized for acute heart failure jugular and renal ultrasound (optional) 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
- Primary Outcome Measures
Name Time Method Rate of day-hospital or at-home IV diuretics injection for acute HF at 3 months after hospital discharge 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)
Rate of all-cause death at 3 months after hospital discharge 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)
Rate of rehospitalization for acute heart failure at 3 months after hospital discharge 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)
- Secondary Outcome Measures
Name Time Method NYHA class 3 months after hospital discharge NYHA class (1, 2, 3, 4)
Ultrasound congestion markers at admission and at final discharge (an average of 10 days after admission) B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion
Rate of all-cause death 12 and 24 months after hospitalization 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 day hospitalization (with outcome 12 and 13)
Rate of day-hospital or in-home IV diuretics injection for acute HF 12 and 24 months after hospitalization 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 day hospitalization (with outcome 11 and 12)
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 Ambrosy Score at admission and at final discharge
Clinical congestion markers as assessed with the ASCEND 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
Natriuretic peptides at admission and at final discharge (an average of 10 days after admission) Natriuretic peptides at admission and at final discharge
Estimated plasma volume at admission and at final discharge (an average of 10 days after admission) Estimated plasma volume at admission and at final discharge
Residual congestion at final discharge (an average of 10 days after admission) as defined as an Ambrosy score 3 or more and/or B-lines score 30 or more and/or an IVC\>21 and IVC collapse with sniff \<50%
Rate of hospitalization for acute heart failure 12 and 24 months after hospitalization 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 day hospitalization (with outcome 11 and 13)
Rate of day-hospital for Intravenous diuretics administration for acute HF 3, 12 and 24 months after hospitalization To identify the markers of congestion (clinical, biological, and ultrasonographic), at the end of hospitalization for ICA most strongly associated with the risk of intravenous administration of diuretics in day-hospital for ICA at 3,12, and 24 months after hospital discharge.
Trial Locations
- Locations (2)
CHR Metz-Thionville - Hôpital de Mercy
🇫🇷Metz, Lorraine, France
CHRU Nancy Hôpitaux de Brabois
🇫🇷Vandœuvre-lès-Nancy, Lorraine, France