Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation (AHF-CODE-P)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Acute Heart Failure

Treatments: 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; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04343430

2019PI188-2

Details and patient eligibility

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

170 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:

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

Procedure: Telephone interview

Procedure: Clinical examination centered on congestion

Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

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