Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation (AHF-CODE-R)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Acute Heart Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04343443

2019PI188-3

Details and patient eligibility

About

The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalised for acute heart failure.
• Patients with reduced ejection fraction (Ejection Fraction <40%) or (40% ≤ Ejection Fraction < 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients hospitalized for acute heart failure

Other group

Description:

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

Treatment:

Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Procedure: Clinical examination centered on congestion

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

Procedure: Biological: Blood sample retrieved for biological assessment and biobanking

Procedure: Telephone interview