About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Clinical examination centered on congestion
Procedure/SurgeryClinical 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
Procedure/SurgeryCardio-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/SurgeryBlood sample collection will be performed before discharge from hospital
Telephone interview
Procedure/SurgeryTelephone interview will be performed at 3, 12 months and 24 months after discharge from Hospital
Kansas City Cardiomyopathy Questionnaire (KCCQ)
BehavioralQuestionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
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)
Secondary outcomes
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)
Rate of re-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 4)
rate of day-hospital or in home IV diuretics injection for acute HF
Rate of all-cause death
Rate of all-cause death at 3, 12 and 24 months after hospital discharge
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