Acute Heart Failure - COngestion Discharge Evaluation (AHF-CODE)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Acute Heart Failure

Treatments: Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ); Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography; Procedure: Telephone follow-up; Procedure: Blood sample retrieved for biological assessment and biobanking

Study type: Interventional

Funder types: Other

Identifiers

NCT04332692

2019-A03311-56

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

Patients hospitalized for acute heart failure

Experimental group

Description:

Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up

Treatment:

Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography

Procedure: Clinical examination centered on congestion

Procedure: Telephone follow-up

Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Procedure: Blood sample retrieved for biological assessment and biobanking