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.

NCT ID: NCT05297630

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2022-07-09

Brief Summary

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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Jet Echo group

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

Evaluation of the evolution of biological markers from the biobank.

Intervention Type: OTHER

The evolution of sST2, copeptin, chromogranin, NGAL, suPAR and cystatin will be evaluated between Day 0 and Month 1

Conventional management group

Biological markers from heart failure patients who had conventional management.

Evaluation of the evolution of biological markers from the biobank.

Intervention Type: OTHER

The evolution of sST2, copeptin, chromogranin, NGAL, suPAR and cystatin will be evaluated between Day 0 and Month 1

Interventions

Evaluation of the evolution of biological markers from the biobank.

The evolution of sST2, copeptin, chromogranin, NGAL, suPAR and cystatin will be evaluated between Day 0 and Month 1

Intervention Type: OTHER

Eligibility Criteria

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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nîmes University Hospital

Nîmes, Gard, France

Montpellier University Hospital, Arnaud de Villeneuve

Montpellier, Hérault, France

Countries

France

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Other Identifiers

AOI/2020/JET01

Identifier Type: -

Identifier Source: org_study_id