Comparative Evaluation of the Evolution of Emerging Biological Markers in Patients Hospitalized for Acute Heart Failure According to Conventional Management or Therapeutic Adjustment Via Daily Ultrasound. (JECICA2)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Heart Failure

Treatments: Other: Evaluation of the evolution of biological markers from the biobank.

Study type: Observational

Funder types: Other

Identifiers

NCT05297630

AOI/2020/JET01

Details and patient eligibility

About

This is a bi-centric, prospective randomized study to evaluate the contribution of rapid echocardioscopy at the patient's bedside to improving the prognosis of patients hospitalized for acute heart failure. The following markers will be evaluated: sST2, Copeptin, chromogranin, NGAL, suPAR and cystatin.

Full description

The JECICA study is the first prospective randomized study to evaluate the contribution of rapid echocardioscopy at the patient's bedside to improving the prognosis of patients hospitalized for acute heart failure (paper submitted to the American Heart Journal, Impact Factor 4.15). The serum library set up to consider this ancillary study can now be used.

With it, a comparative analysis of the expression profiles of emerging biological markers will be made according to whether patients received standard management or the "Jet Echo" strategy. The following markers will be evaluated: sST2, Copeptin, chromogranin, NGAL, suPAR and cystatin. This study should help to explain any differences in results observed, consider the development of multiparametric prognostic scores and explore the correlation between biological markers and the evaluation of echocardiographic congestion from a pathophysiological viewpoint.

The results obtained should lead us to improve our usual practices for the management of heart failure patients.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (General inclusion criteria)

• The patient or his representative must have given free and informed consent and signed the consent form.
• The patient must be affiliated to or beneficiary of a health insurance plan.
• The patient must have been available for 6 months of follow-up.
• The patient is at least (>) 18 years of age.

Inclusion criteria for target population:

• Patient hospitalized for acute heart failure who received at least 40mg of IV furosemide.
• Patient with impaired Left Ventricle Ejection Fraction <50%.
• Patient with an Nt-ProBNP value >1200pg/ml.

Exclusion Criteria : (General non-inclusion criteria)

• Subject is participating in another study.
• Subject is in an exclusion period determined by a previous study.
• Subject is under court protection.
• Subject or subject's representative refuses to sign consent.
• It is not possible to provide the subject or the subject's representative with informed information.

Criteria for non-inclusion regarding associated interfering diseases or conditions:

• Patient is pregnant or breastfeeding.
• Patient is already included in a surveillance program (PRADO, OSICAT).
• Patient has a mechanical or biological mitral prosthesis.
• History of mitral narrowing.
• Severe valve disease with a surgical deadline within a month (<30 days).
• Chronic renal failure on dialysis.
• High grade BAV (BAV 2/1 and BAV3).
• Hypertrophic cardiomyopathy.
• Cardiogenic shock.
• Contraindication to furosemide.
• Anechoic patient.

Exclusion criteria:

• Patient hospitalized for more than (>) 1 month.

Trial design

169 participants in 2 patient groups

Jet Echo group

Description:

Biological markers from heart failure patients who underwent therapeutic adjustment according to a daily ultrasound scan

Treatment:

Other: Evaluation of the evolution of biological markers from the biobank.

Conventional management group

Description:

Biological markers from heart failure patients who had conventional management.

Treatment:

Other: Evaluation of the evolution of biological markers from the biobank.