Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation
Recruiting · NCT04343430 · Interventional (participants receive a specific treatment) · Lead sponsor: Central Hospital, Nancy, France
View the official record on ClinicalTrials.gov →Interventions studied
Biological: Blood sample retrieved for biological assessment and biobankingCardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyClinical examination centered on congestionKansas City Cardiomyopathy Questionnaire (KCCQ)Telephone interview
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- CHRU de Nancy - Vandœuvre-lès-Nancy, France