Clinical trial NCT05297630: 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.
Official title: Comparative Evaluation of the Evolution of Emerging Biological Markers (sST2, Copeptin, Chromogranin, NGAL, suPAR and Cystatin) in Patients Hospitalized for Acute Heart Failure (AHF) Depending on Their Management: Conventional or Therapeutic Adjustment According to Daily Ultrasound. Ancillary Study to the JECICA Study (AOI GCS MERRI 2015).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
hospitalization
biomarkers
sST2
prognosis
therapeutic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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.

Primary outcomes:
measure: Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
timeFrame: 1 Month
measure: Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
timeFrame: 1 Month
measure: Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
timeFrame: Day 0
measure: Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
timeFrame: Month 1
measure: Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
timeFrame: Day 0
measure: Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
timeFrame: Month 1
measure: Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
timeFrame: Day 0
measure: Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
timeFrame: Month 1
measure: Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
timeFrame: Day 0
measure: Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
timeFrame: Month 1
measure: Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
timeFrame: Month 1
measure: Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
timeFrame: Month 1
measure: Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
timeFrame: Month 1
measure: Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
timeFrame: Month 1
measure: Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
timeFrame: Month 1
measure: Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
timeFrame: Day 0
measure: Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
timeFrame: Month 1
Secondary outcomes:
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy
timeFrame: Month 1
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy
timeFrame: Day 0
measure: Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy
timeFrame: Month 1
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
city: Montpellier
country: France
facility: Montpellier University Hospital, Arnaud de Villeneuve
state: Hérault
Study officials:
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