JECICA2: 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.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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. |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group. [1 Month]
Quantitative, ng/mL
- Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group. [1 Month]
Quantitative, ng/mL
- Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group [Day 0]
Quantitative, pmol/L
- Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group [Month 1]
Quantitative, pmol/L
- Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group [Day 0]
Quantitative, pmol/L
- Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group [Month 1]
Quantitative, pmol/L
- Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group. [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group. [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group. [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group. [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group. [Month 1]
Quantitative, ng/mL
- Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group. [Day 0]
Quantitative, ng/mL
- Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group. [Month 1]
Quantitative, ng/mL
Secondary Outcome Measures
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex [Day 0]
The sex of participants will be noted as Male/Female
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex [Day 0]
The sex of participants will be noted as Male/Female
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age [Day 0]
The age of participants will be noted in years
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age [Day 0]
The age of participants will be noted in years
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis [Day 0]
The diuresis of participants will be measured in millilitres
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis [Month 1]
The diuresis of participants will be measured in millilitres
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis [Day 0]
The diuresis of participants will be measured in millilitres
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis [Month 1]
The diuresis of participants will be measured in millilitres
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure [Day 0]
The blood pressure of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure [Month 1]
The blood pressure of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure [Day 0]
The blood pressure of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure [Month 1]
The blood pressure of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate [Day 0]
The heart rate of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate [Month 1]
The heart rate of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate [Day 0]
The heart rate of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate [Month 1]
The heart rate of participants will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors [Day 0]
Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors [Month 1]
Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors [Day 0]
Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors [Month 1]
Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history [Day 0]
The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history [Month 1]
The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history [Day 0]
The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history [Month 1]
The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction [Day 0]
The Left ventricle Ejection Fraction will be measured as a %.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction [Month 1]
The Left ventricle Ejection Fraction will be measured as a %.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction [Day 0]
The Left ventricle Ejection Fraction will be measured as a %.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction [Month 1]
The Left ventricle Ejection Fraction will be measured as a %.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage [Day 0]
The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage [Month 1]
The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage [Day 0]
The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage [Month 1]
The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage [Day 0]
The New York Heart Association stage will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage [Month 1]
The New York Heart Association stage will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage [Day 0]
The New York Heart Association stage will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage [Month 1]
The New York Heart Association stage will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure [Day 0]
The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure [Month 1]
The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure [Day 0]
The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure [Month 1]
The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy [Day 0]
The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy [Month 1]
The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy [Day 0]
The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy [Month 1]
The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.
Eligibility Criteria
Criteria
Inclusion Criteria: (General inclusion criteria)
-
The patient or his representative must have given free and informed consent and signed the consent form.
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The patient must be affiliated to or beneficiary of a health insurance plan.
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The patient must have been available for 6 months of follow-up.
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The patient is at least (>) 18 years of age.
Inclusion criteria for target population:
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Patient hospitalized for acute heart failure who received at least 40mg of IV furosemide.
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Patient with impaired Left Ventricle Ejection Fraction <50%.
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Patient with an Nt-ProBNP value >1200pg/ml.
Exclusion Criteria : (General non-inclusion criteria)
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Subject is participating in another study.
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Subject is in an exclusion period determined by a previous study.
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Subject is under court protection.
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Subject or subject's representative refuses to sign consent.
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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:
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Patient is pregnant or breastfeeding.
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Patient is already included in a surveillance program (PRADO, OSICAT).
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Patient has a mechanical or biological mitral prosthesis.
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History of mitral narrowing.
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Severe valve disease with a surgical deadline within a month (<30 days).
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Chronic renal failure on dialysis.
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High grade BAV (BAV 2/1 and BAV3).
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Hypertrophic cardiomyopathy.
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Cardiogenic shock.
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Contraindication to furosemide.
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Anechoic patient.
Exclusion criteria:
- Patient hospitalized for more than (>) 1 month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nîmes University Hospital | Nîmes | Gard | France | 30029 |
| 2 | Montpellier University Hospital, Arnaud de Villeneuve | Montpellier | Hérault | France | 34295 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- AOI/2020/JET01