Clinical trial NCT04343430: Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation
Official title: Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of all-cause death
timeFrame: 3 months after hospital discharge
measure: Rate of re-hospitalisation for acute heart failure
timeFrame: 3 months after hospital discharge
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 3 months after hospital discharge
Secondary outcomes:
measure: Rate of all-cause death
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of re-hospitalisation for acute heart failure
timeFrame: 3, 12 and 24 months after hospital discharge
measure: rate of day-hospital or in home IV diuretics injection for acute HF
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of all-cause death
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of hospitalisation for acute heart failure
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of all-cause death
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of hospitalisation for acute heart failure
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of death from all causes
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Rate of hospitalisation for acute heart failure
timeFrame: 3, 12 and 24 months after hospital discharge
measure: NYHA (New York Heart Association) class
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Natriuretic peptides
timeFrame: At inclusion
measure: Renal function assessed by glomerular filtration rate
timeFrame: At inclusion
measure: Plasma volume
timeFrame: At inclusion
measure: Blood potassium
timeFrame: At inclusion
measure: Liver elastography value
timeFrame: At inclusion
measure: Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
timeFrame: At inclusion and 3, 6 and 24 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: