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.

Heart Failure Clinical Trial

— JECICA2  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297630
• Other study ID #: AOI/2020/JET01
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: July 9, 2022

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: July 9, 2022
• Est. primary completion date: July 9, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	Montpellier University Hospital, Arnaud de Villeneuve	Montpellier	Hérault
France	Nîmes University Hospital	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (23)

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Lotierzo M, Dupuy AM, Kalmanovich E, Roubille F, Cristol JP. sST2 as a value-added biomarker in heart failure. Clin Chim Acta. 2020 Feb;501:120-130. doi: 10.1016/j.cca.2019.10.029. Epub 2019 Oct 31. Review. — View Citation

McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. Erratum in: Eur J Heart Fail. 2013 Mar;15(3):361-2. — View Citation

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Ovbiagele B, Goldstein LB, Higashida RT, Howard VJ, Johnston SC, Khavjou OA, Lackland DT, Lichtman JH, Mohl S, Sacco RL, Saver JL, Trogdon JG; American Heart Association Advocacy Coordinating Committee and Stroke Council. Forecasting the future of stroke in the United States: a policy statement from the American Heart Association and American Stroke Association. Stroke. 2013 Aug;44(8):2361-75. doi: 10.1161/STR.0b013e31829734f2. Epub 2013 May 22. Erratum in: Stroke. 2015 Jul;46(7):e179. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.	Quantitative, ng/mL	1 Month
Primary	Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.	Quantitative, ng/mL	1 Month
Primary	Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group	Quantitative, pmol/L	Day 0
Primary	Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group	Quantitative, pmol/L	Month 1
Primary	Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group	Quantitative, pmol/L	Day 0
Primary	Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group	Quantitative, pmol/L	Month 1
Primary	Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.	Quantitative, ng/mL	Month 1
Primary	Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.	Quantitative, ng/mL	Day 0
Primary	Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.	Quantitative, ng/mL	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex	The sex of participants will be noted as Male/Female	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex	The sex of participants will be noted as Male/Female	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age	The age of participants will be noted in years	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age	The age of participants will be noted in years	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis	The diuresis of participants will be measured in millilitres	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis	The diuresis of participants will be measured in millilitres	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis	The diuresis of participants will be measured in millilitres	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis	The diuresis of participants will be measured in millilitres	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure	The blood pressure of participants will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure	The blood pressure of participants will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure	The blood pressure of participants will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure	The blood pressure of participants will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate	The heart rate of participants will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate	The heart rate of participants will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate	The heart rate of participants will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate	The heart rate of participants will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors	Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors	Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors	Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors	Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history	The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history	The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history	The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history	The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction	The Left ventricle Ejection Fraction will be measured as a %.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction	The Left ventricle Ejection Fraction will be measured as a %.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction	The Left ventricle Ejection Fraction will be measured as a %.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction	The Left ventricle Ejection Fraction will be measured as a %.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage	The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage	The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage	The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage	The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage	The New York Heart Association stage will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage	The New York Heart Association stage will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage	The New York Heart Association stage will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage	The New York Heart Association stage will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure	The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure	The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure	The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure	The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy	The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy	The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.	Month 1
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy	The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.	Day 0
Secondary	Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy	The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.	Month 1