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.

An observational study of Heart Failure, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Evaluation of the evolution of biological markers from the biobank.
How many people: 169 participants
Where: 2 sitesFrance
Study dates: 15 Feb 2022to 9 Jul 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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).

Who may be able to join

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.
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.

Who cannot join

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:

Show all 18Show fewer

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.
Patient hospitalized for more than (>) 1 month.

Trial locations and contacts

2 sites in 1 country.

France2 sites

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

Other trials in France

About this study

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).

Read the 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.

Conditions: Heart Failure
Being tested: Evaluation of the evolution of biological markers from the biobank.
Keywords: Heart failure, hospitalization, biomarkers, sST2, prognosis, therapeutic
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evaluation of the evolution of biological markers from the biobank.Other
The evolution of sST2, copeptin, chromogranin, NGAL, suPAR and cystatin will be evaluated between Day 0 and Month 1

Study groups in NCT05297630
Study group	Role	What they receive
Jet Echo group		Biological markers from heart failure patients who underwent therapeutic adjustment according to a daily ultrasound scan Receives: Other: Evaluation of the evolution of biological markers from the biobank.
Conventional management group		Biological markers from heart failure patients who had conventional management. Receives: Other: Evaluation of the evolution of biological markers from the biobank.

What is being measured

The primary outcome is the main question the study is designed to answer.

Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: 1 Month
Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: 1 Month
Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
Quantitative, pmol/L
Measured: Day 0
Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
Quantitative, pmol/L
Measured: Month 1
Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
Quantitative, pmol/L
Measured: Day 0
Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
Quantitative, pmol/L
Measured: Month 1
Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
Quantitative, ng/mL
Measured: Month 1
Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Day 0
Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
Quantitative, ng/mL
Measured: Month 1

Secondary outcomes (44)

Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex
The sex of participants will be noted as Male/Female
Measured: 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
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age
The age of participants will be noted in years
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age
The age of participants will be noted in years
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
The diuresis of participants will be measured in millilitres
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
The diuresis of participants will be measured in millilitres
Measured: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
The diuresis of participants will be measured in millilitres
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
The diuresis of participants will be measured in millilitres
Measured: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
The blood pressure of participants will be noted
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
The blood pressure of participants will be noted
Measured: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
The blood pressure of participants will be noted
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
The blood pressure of participants will be noted
Measured: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
The heart rate of participants will be noted
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
The heart rate of participants will be noted
Measured: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
The heart rate of participants will be noted
Measured: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
The heart rate of participants will be noted
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 %.
Measured: 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 %.
Measured: 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 %.
Measured: 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 %.
Measured: 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.
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.
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.
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.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20229 Jul 2022

First posted28 Mar 2022
Study start15 Feb 2022
Primary completion9 Jul 2022
Study completion9 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05297630
Sponsor's protocol ID: AOI/2020/JET01
Acronym: JECICA2
Status last verified: Jul 2022
First submitted: 17 Mar 2022
Last updated: 27 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 17531592
Capomolla S, Ceresa M, Pinna G, Maestri R, La Rovere MT, Febo O, Rossi A, Paganini V, Caporotondi A, Guazzotti G, Gnemmi M, Mortara A, Cobelli F. Echo-Doppler and clinical evaluations to define hemodynamic profile in patients with chronic heart failure: accuracy and influence on therapeutic management. Eur J Heart Fail. 2005 Jun;7(4):624-30. doi: 10.1016/j.ejheart.2004.07.013.
PubMed 15921804
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.
PubMed 1825901
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.
PubMed 19215829
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.
PubMed 24446411
Goonewardena SN, Spencer KT. Handcarried echocardiography to assess hemodynamics in acute decompensated heart failure. Curr Heart Fail Rep. 2010 Dec;7(4):219-27. doi: 10.1007/s11897-010-0030-8.
PubMed 20890689
Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
PubMed 21262990
Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13.
PubMed 32168423
Lei J, Dhamoon AS, Wang J, Iannuzzi M, Liu K. Walking the tightrope: Using quantitative Doppler echocardiography to optimize ventricular filling pressures in patients hospitalized for acute heart failure. Eur Heart J Acute Cardiovasc Care. 2016 Apr;5(2):130-40. doi: 10.1177/2048872615573517. Epub 2015 Feb 18.
PubMed 25694508
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.
PubMed 31678574
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.
PubMed 22828712
Metra M, Cotter G, Gheorghiade M, Dei Cas L, Voors AA. The role of the kidney in heart failure. Eur Heart J. 2012 Sep;33(17):2135-42. doi: 10.1093/eurheartj/ehs205. Epub 2012 Aug 10.
PubMed 22888113
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.
PubMed 18760138
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.
PubMed 23697546
Parrinello G, Torres D, Paterna S, Di Pasquale P, Mezzero M, Licata G. The challenge of the volume status assessment in heart failure. Am Heart J. 2009 Apr;157(4):e19-20; author reply e21. doi: 10.1016/j.ahj.2008.12.001. Epub 2009 Jan 31. No abstract available.
PubMed 19332179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT05297630
Acronym / sponsor ID: JECICA2 / AOI/2020/JET01
Conditions: Heart Failure
Keywords: Heart failure, hospitalization, biomarkers, sST2, prognosis, therapeutic
Study type: Observational
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
Study start: 15 Feb 2022 (actual)
Primary completion: 9 Jul 2022 (actual)
Study completion: 9 Jul 2022 (actual)
First posted: 28 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The results obtained should lead us to improve our usual practices for the management of heart failure patients.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Jet Echo group	–	Other: 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
Conventional management group	–	Other: Evaluation of the evolution of biological markers from the biobank.Biological markers from heart failure patients who had conventional management.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
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).

Key inclusion criteria (7 listed)

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.
Patient hospitalized for acute heart failure who received at least 40mg of IV furosemide.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Other	Conventional management group, Jet Echo group

Primary outcome

Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
Time frame: 1 Month
Quantitative, ng/mL
Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
Time frame: 1 Month
Quantitative, ng/mL
Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
Time frame: Day 0
Quantitative, pmol/L
Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
Time frame: Month 1
Quantitative, pmol/L
Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
Time frame: Day 0
Quantitative, pmol/L
Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
Time frame: Month 1
Quantitative, pmol/L
Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
Time frame: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
Time frame: Day 0
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
Time frame: Month 1
Quantitative, ng/mL

44 secondary outcomes

Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure
Time frame: Month 1
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure
Time frame: Day 0
Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure
Time frame: Month 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Background: PubMed 17531592Brennan 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.
Background: PubMed 15921804Capomolla S, Ceresa M, Pinna G, Maestri R, La Rovere MT, Febo O, Rossi A, Paganini V, Caporotondi A, Guazzotti G, Gnemmi M, Mortara A, Cobelli F. Echo-Doppler and clinical evaluations to define hemodynamic profile in patients with chronic heart failure: accuracy and influence on therapeutic management. Eur J Heart Fail. 2005 Jun;7(4):624-30. doi: 10.1016/j.ejheart.2004.07.013.
Background: PubMed 1825901Chakko 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.
Background: PubMed 19215829Gheorghiade 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.
Background: PubMed 24446411Go 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.
Background: PubMed 20890689Goonewardena SN, Spencer KT. Handcarried echocardiography to assess hemodynamics in acute decompensated heart failure. Curr Heart Fail Rep. 2010 Dec;7(4):219-27. doi: 10.1007/s11897-010-0030-8.
Background: PubMed 21262990Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
Background: PubMed 32168423Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13.
Background: PubMed 25694508Lei J, Dhamoon AS, Wang J, Iannuzzi M, Liu K. Walking the tightrope: Using quantitative Doppler echocardiography to optimize ventricular filling pressures in patients hospitalized for acute heart failure. Eur Heart J Acute Cardiovasc Care. 2016 Apr;5(2):130-40. doi: 10.1177/2048872615573517. Epub 2015 Feb 18.
Background: PubMed 31678574Lotierzo 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.
Background: PubMed 22828712McMurray 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.
Background: PubMed 22888113Metra M, Cotter G, Gheorghiade M, Dei Cas L, Voors AA. The role of the kidney in heart failure. Eur Heart J. 2012 Sep;33(17):2135-42. doi: 10.1093/eurheartj/ehs205. Epub 2012 Aug 10.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group. (time frame: Day 0). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297630, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.