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.

NCT05297630 | Completed

• 1 other identifier: AOI/2020/JET01
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Heart failure; hospitalization; biomarkers; sST2; prognosis; therapeutic

Outcome Measures

Primary Outcomes (24)

• Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  1 Month

• Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.

  Quantitative, ng/mL

  1 Month

• Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group

  Quantitative, pmol/L

  Day 0

• Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group

  Quantitative, pmol/L

  Month 1

• Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group

  Quantitative, pmol/L

  Day 0

• Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group

  Quantitative, pmol/L

  Month 1

• Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.

  Quantitative, ng/mL

  Month 1

• Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Day 0

• Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.

  Quantitative, ng/mL

  Month 1

Secondary Outcomes (44)

• Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex

  Day 0

• Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex

  Day 0

• Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age

  Day 0

• Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age

  Day 0

• Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis

  Day 0

Study Arms (2)

Jet Echo group

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

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

Conventional management group

Biological markers from heart failure patients who had conventional management.

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

Interventions

Evaluation of the evolution of biological markers from the biobank. OTHER

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

Conventional management group; Jet Echo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Serum library already constituted from the population of the original JECICA study whose selection criteria are described above (samples available from 169 patients, collected at D0 and at 1 month).

You may qualify if:

• 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.

You may not qualify if:

• Subject is participating in another 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

Montpellier University Hospital, Arnaud de Villeneuve

Montpellier, Hérault, 34295, France

Location

Related Publications (23)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The samples analyzed in the JECICA2 study come from the serum library already constituted from the population of the original JECICA study, the selection criteria of which are as follows (samples available from 169 patients, collected at D0 and 1 month). Patients hospitalized for acute heart failure who received at least 40mg of IV furosemide. Patients with impaired Left Ventricular Ejection Fraction, \<50%. Patients with an Nt-ProBNP value \>1200pg/ml.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: February 15, 2022
• Primary Completion: July 9, 2022
• Study Completion: July 9, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

FR (2)