Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Acute Heart Failure

Treatments: Biological: Blood sample retrieved for biological assessment and biobanking; Procedure: Cardio-pulmonary and peritoneal ultrasound; Procedure: jugular and renal ultrasound (optional); Procedure: Clinical examination centered on congestion; Biological: Urinary sample retrieved for biological assessment and biobanking; Other: Telephone interview

Study type: Interventional

Funder types: Other

Identifiers

NCT03327532

2017-A01455-48

Details and patient eligibility

About

The AHF-CORE study is a prospective, non-randomized, multicenter regional study.

The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.

Secondary objectives are:

• Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure.
• Assess the correlation between changes in congestion markers between the beginning and end of hospitalization.
• Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization.
• Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.
• Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge

Full description

Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge.

Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected.

Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital
• Patients over 18 years old
• Person affiliated to or beneficiary of a social security plan
• Person informed about study organization and having signed the informed consent

Exclusion criteria

• Comorbidity for which life expectancy is ≤ 3 months
• Diagnosis of heart failure made less than 3 months prior to inclusion
• Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation)
• Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline
• History of pulmonary lobectomy or pneumonectomy
• Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis
• Suspected cardiac amylose or proven cardiac amylose
• Woman of childbearing age without effective contraception
• Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
• Persons deprived of liberty for judicial or administrative decision
• Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Patients hospitalized for acute heart failure

Experimental group

Description:

One arm study. Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary and peritoneal ultrasound * Blood sample retrieved for biological assessment and biobanking * Telephone interview

Treatment:

Procedure: jugular and renal ultrasound (optional)

Other: Telephone interview

Biological: Blood sample retrieved for biological assessment and biobanking

Procedure: Cardio-pulmonary and peritoneal ultrasound

Procedure: Clinical examination centered on congestion

Biological: Urinary sample retrieved for biological assessment and biobanking