Clinical trial NCT04332692: Acute Heart Failure - COngestion Discharge Evaluation
Official title: Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Heart Failure
Keywords: Acute Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 110
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: Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .

Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalised for acute heart failure.
* 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: 12 and 24 months after hospital discharge
measure: Rate of re-hospitalisation for acute heart failure
timeFrame: 12 and 24 months after hospital discharge
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 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 hospitalization 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: NYHA (New York Heart Association) class measured
timeFrame: 3, 12 and 24 months after hospital discharge
measure: Natriuretic peptides
timeFrame: within 24 months after hospital discharge.
measure: Renal function assessed by glomerular filtration rate
timeFrame: within 24 months after hospital discharge.
measure: Plasma volume
timeFrame: within 24 months after hospital discharge.
measure: Liver elastography value
timeFrame: At inclusion
measure: Quality of life
timeFrame: At inclusion and 3, 6 and 24 months
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU of Nancy
name: Nicolas GIRERD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: