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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients hospitalized for acute heart failure | Experimental | One arm study. Patients hospitalized for acute heart failure will undergo the following evaluations:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examination centered on congestion | Procedure | Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause death | 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) | at 3 months after hospital discharge |
| Rate of rehospitalization for acute heart failure | 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) | at 3 months after hospital discharge |
| Rate of day-hospital or at-home IV diuretics injection for acute HF | 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) | at 3 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical congestion markers as assessed with the Ambrosy Score | Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge | at admission and at final discharge (an average of 10 days after admission) |
| Clinical congestion markers as assessed with the ASCEND score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GIRERD, MD,PhD | Contact | + 33 3 83 15 74 96 | + 33 3 | n.girerd@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GIRERD, MD,PhD | Centre d'Investigation Clinique 1433 module Plurithématique de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Metz-Thionville - Hôpital de Mercy | Recruiting | Metz | Lorraine | 57000 | France |
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| Cardio-pulmonary and peritoneal ultrasound | Procedure | Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital |
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| Blood sample retrieved for biological assessment and biobanking | Biological | Blood sample collection will be performed within 72 hours of admission and before discharge from hospital |
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| Telephone interview | Other | Telephone interview will be performed 3, 12 and 24 months after discharge from hospital |
|
| Urinary sample retrieved for biological assessment and biobanking | Biological | Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital |
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| jugular and renal ultrasound (optional) | Procedure | optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital |
|
Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge |
| at admission and at final discharge (an average of 10 days after admission) |
| Natriuretic peptides | Natriuretic peptides at admission and at final discharge | at admission and at final discharge (an average of 10 days after admission) |
| Estimated plasma volume | Estimated plasma volume at admission and at final discharge | at admission and at final discharge (an average of 10 days after admission) |
| Ultrasound congestion markers | B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion | at admission and at final discharge (an average of 10 days after admission) |
| Residual congestion | 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% | at final discharge (an average of 10 days after admission) |
| NYHA class | NYHA class (1, 2, 3, 4) | 3 months after hospital discharge |
| Rate of day-hospital for Intravenous diuretics administration for acute HF | 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. | 3, 12 and 24 months after hospitalization |
| Rate of all-cause death | 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) | 12 and 24 months after hospitalization |
| Rate of hospitalization for acute heart failure | 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) | 12 and 24 months after hospitalization |
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 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) | 12 and 24 months after hospitalization |
| CHRU Nancy Hôpitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | Lorraine | 54500 | France |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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