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The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.
The main objective of the AHF-CODE preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients hospitalized for acute heart failure | Other | 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 (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause death | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3) | 3 months after hospital discharge |
| Rate of re-hospitalisation for acute heart failure | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 1 and 3) | 3 months after hospital discharge |
| Rate of day-hospital or in-home IV diuretics injection for acute HF | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3) | 3 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause death | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3,12 and 24 months after hospital discharge (with outcome 5) | 3, 12 and 24 months after hospital discharge |
| Rate of re-hospitalisation for acute heart failure |
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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 73 22 | + 33 3 | n.girerd@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography | Procedure | Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital |
|
| Biological: Blood sample retrieved for biological assessment and biobanking | Procedure | Blood sample collection will be performed before discharge from hospital |
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| Telephone interview | Procedure | Telephone interview will be performed at 3, 12 months and 24 months after discharge from Hospital |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Behavioral | Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge |
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composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 4) |
| 3, 12 and 24 months after hospital discharge |
| rate of day-hospital or in home IV diuretics injection for acute HF | 3, 12 and 24 months after hospital discharge |
| Rate of all-cause death | Rate of all-cause death at 3, 12 and 24 months after hospital discharge | 3, 12 and 24 months after hospital discharge |
| Rate of hospitalisation for acute heart failure | Rate of hospitalisation for acute heart Failure at 3, 12 and 24 months after hospital discharge | 3, 12 and 24 months after hospital discharge |
| Rate of all-cause death | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 10) | 3, 12 and 24 months after hospital discharge |
| Rate of hospitalisation for acute heart failure | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 9) | 3, 12 and 24 months after hospital discharge |
| Rate of death from all causes | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 12) | 3, 12 and 24 months after hospital discharge |
| Rate of hospitalisation for acute heart failure | composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 11) | 3, 12 and 24 months after hospital discharge |
| NYHA (New York Heart Association) class | 3, 12 and 24 months after hospital discharge |
| Natriuretic peptides | BNP or Nt-Pro BNP | At inclusion |
| Renal function assessed by glomerular filtration rate | At inclusion |
| Plasma volume | Calculated from haemoglobin and haematocrit value | At inclusion |
| Blood potassium | At inclusion |
| Liver elastography value | Measured with Fibroscan® | At inclusion |
| Quality of life assessed by Kansas City Cardiomyopathy Questionnaire | Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | At inclusion and 3, 6 and 24 months |
| 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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