Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation
- Conditions
- Acute Heart Failure
- Interventions
- Procedure: Clinical examination centered on congestionProcedure: Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyProcedure: Telephone interviewBehavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Registration Number
- NCT04343430
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients hospitalized for acute heart failure Clinical examination centered on congestion Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone interview Patients hospitalized for acute heart failure Kansas City Cardiomyopathy Questionnaire (KCCQ) Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone interview Patients hospitalized for acute heart failure Telephone interview Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone interview Patients hospitalized for acute heart failure Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone interview
- Primary Outcome Measures
Name Time Method 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 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)
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)
- Secondary Outcome Measures
Name Time Method Quality of life assessed by Kansas City Cardiomyopathy Questionnaire At inclusion and 3, 6 and 24 months Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Rate of 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 11)
NYHA (New York Heart Association) class 3, 12 and 24 months after hospital discharge 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 months after hospital discharge (with outcome 10)
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)
Natriuretic peptides At inclusion BNP or Nt-Pro BNP
Renal function assessed by glomerular filtration rate At inclusion Plasma volume At inclusion Calculated from haemoglobin and haematocrit value
Liver elastography value At inclusion Measured with Fibroscan®
rate of day-hospital or in home IV diuretics injection for acute HF 3, 12 and 24 months after hospital discharge Blood potassium At inclusion 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)
Trial Locations
- Locations (1)
CHRU de Nancy
🇫🇷Vandœuvre-lès-Nancy, France