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. (JECICA2)

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).

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Evaluation of the evolution of biological markers from the biobank.

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 Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Nîmes University Hospital
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Montpellier University Hospital, Arnaud de Villeneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age	The age of participants will be noted in years	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age	The age of participants will be noted in years	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis	The diuresis of participants will be measured in millilitres	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis	The diuresis of participants will be measured in millilitres	Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis	The diuresis of participants will be measured in millilitres	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis	The diuresis of participants will be measured in millilitres	Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure	The blood pressure of participants will be noted	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure	The blood pressure of participants will be noted	Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure	The blood pressure of participants will be noted	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure	The blood pressure of participants will be noted	Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate	The heart rate of participants will be noted	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate	The heart rate of participants will be noted	Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate	The heart rate of participants will be noted	Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate	The heart rate of participants will be noted	Month 1
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

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• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.
• Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidan MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10.
• Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.
• Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.
• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik 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. No abstract available. Erratum In: Eur J Heart Fail. 2013 Mar;15(3):361-2.
• Chakko S, Woska D, Martinez H, de Marchena E, Futterman L, Kessler KM, Myerberg RJ. Clinical, radiographic, and hemodynamic correlations in chronic congestive heart failure: conflicting results may lead to inappropriate care. Am J Med. 1991 Mar;90(3):353-9. doi: 10.1016/0002-9343(91)80016-f.
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• Nguyen VT, Ho JE, Ho CY, Givertz MM, Stevenson LW. Handheld echocardiography offers rapid assessment of clinical volume status. Am Heart J. 2008 Sep;156(3):537-42. doi: 10.1016/j.ahj.2008.04.015. Epub 2008 Jun 17.
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Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): July 9, 2022
• Study Completion (Actual): July 9, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; Heart failure; prognosis; hospitalization; therapeutic; sST2
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AOI/2020/JET01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No