Acute Heart Failure
Conditions
Brief summary
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.
Interventions
Blood sample collection will be performed before discharge from hospital
Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital
PROCEDURETelephone interview
Telephone interview will be performed at 3, 12 months and 24 months after discharge from Hospital
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients hospitalised for acute heart failure. * Patient with preserved ejection fraction (FE ≥ 50%). * Patients considered clinically discharging from hospitalisation for acute heart failure. * Age ≥18 years * Patients having received complete information regarding the study design and having signed their informed consent form. * Patient affiliated to or beneficiary of a social security scheme.
Exclusion criteria
* Comorbidity for which the life expectancy is ≤ 3 months * Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m² at inclusion. * History of lobectomy or pneumonectomy lung surgery * Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * Pregnant woman, parturient or nursing mother * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * Adult person who is unable to give consent * Person deprived of liberty by a judicial or administrative decision, * Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause death | 3 months after hospital discharge | 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) |
| Rate of re-hospitalisation for acute heart failure | 3 months after hospital discharge | 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) |
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 3 months after hospital discharge | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hospitalisation for acute heart failure | 3, 12 and 24 months after hospital discharge | Rate of hospitalisation for acute heart Failure at 3, 12 and 24 months after hospital discharge |
| Rate of death from all causes | 3, 12 and 24 months after hospital discharge | 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) |
| NYHA (New York Heart Association) class | 3, 12 and 24 months after hospital discharge | — |
| Natriuretic peptides | At inclusion | BNP or Nt-Pro BNP |
| Rate of all-cause death | 3, 12 and 24 months after hospital discharge | 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) |
| Plasma volume | At inclusion | Calculated from haemoglobin and haematocrit value |
| Blood potassium | At inclusion | — |
| Liver elastography value | At inclusion | Measured with Fibroscan® |
| Quality of life assessed by Kansas City Cardiomyopathy Questionnaire | At inclusion and 3, 6 and 24 months | Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) |
| Renal function assessed by glomerular filtration rate | At inclusion | — |
| Rate of re-hospitalisation for acute heart failure | 3, 12 and 24 months after hospital discharge | 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) |
| rate of day-hospital or in home IV diuretics injection for acute HF | 3, 12 and 24 months after hospital discharge | — |
Countries
France
Contacts
Primary ContactNicolas GIRERD, MD,PhD
Outcome results
None listed