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.
- Conditions
- Heart Failure
- Interventions
- Other: Evaluation of the evolution of biological markers from the biobank.
- Registration Number
- NCT05297630
- Lead Sponsor
- Centre Hospitalier Universitaire de NÄ«mes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
(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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional management group Evaluation of the evolution of biological markers from the biobank. Biological markers from heart failure patients who had conventional management. Jet Echo group Evaluation of the evolution of biological markers from the biobank. Biological markers from heart failure patients who underwent therapeutic adjustment according to a daily ultrasound scan
- Primary Outcome Measures
Name Time Method 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. Month 1 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 copeptin in plasma samples from the conventional management group Month 1 Quantitative, pmol/L
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 copeptin in plasma samples from the Jet Echo group Month 1 Quantitative, pmol/L
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. 1 Month 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 Month 1 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. Month 1 Quantitative, ng/mL
- Secondary Outcome Measures
Name Time Method 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 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: heart rate Month 1 The heart rate 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: 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 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 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: 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: Diuresis Month 1 The diuresis of participants will be measured in millilitres
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: 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 Month 1 The diuresis of participants will be measured in millilitres
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 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 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: 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: 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: 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: 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: 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: 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 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 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 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.
Trial Locations
- Locations (2)
Nîmes University Hospital
🇫🇷Nîmes, Gard, France
Montpellier University Hospital, Arnaud de Villeneuve
🇫🇷Montpellier, Hérault, France