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NCT Number: NCT05297630

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.

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nîmes University Hospital, Nîmes, Gard, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.

    Time frame: Day 0

    Quantitative, ng/mL

  2. Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.

    Time frame: 1 Month

    Quantitative, ng/mL

  3. Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.

    Time frame: Day 0

    Quantitative, ng/mL

  4. Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.

    Time frame: 1 Month

    Quantitative, ng/mL

  5. Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group

    Time frame: Day 0

    Quantitative, pmol/L

  6. Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group

    Time frame: Month 1

    Quantitative, pmol/L

  7. Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group

    Time frame: Day 0

    Quantitative, pmol/L

  8. Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group

    Time frame: Month 1

    Quantitative, pmol/L

  9. Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group

    Time frame: Day 0

    Quantitative, ng/mL

  10. Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group

    Time frame: Month 1

    Quantitative, ng/mL

  11. Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group

    Time frame: Day 0

    Quantitative, ng/mL

  12. Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group

    Time frame: Month 1

    Quantitative, ng/mL

  13. Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.

    Time frame: Day 0

    Quantitative, ng/mL

  14. Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.

    Time frame: Month 1

    Quantitative, ng/mL

  15. Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.

    Time frame: Day 0

    Quantitative, ng/mL

  16. Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.

    Time frame: Month 1

    Quantitative, ng/mL

  17. Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.

    Time frame: Day 0

    Quantitative, ng/mL

  18. Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.

    Time frame: Month 1

    Quantitative, ng/mL

  19. Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.

    Time frame: Day 0

    Quantitative, ng/mL

  20. Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.

    Time frame: Month 1

    Quantitative, ng/mL

  21. Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.

    Time frame: Day 0

    Quantitative, ng/mL

  22. Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.

    Time frame: Month 1

    Quantitative, ng/mL

  23. Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.

    Time frame: Day 0

    Quantitative, ng/mL

  24. Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.

    Time frame: Month 1

    Quantitative, ng/mL

Secondary outcomes

  1. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex

    Time frame: Day 0

    The sex of participants will be noted as Male/Female

  2. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex

    Time frame: Day 0

    The sex of participants will be noted as Male/Female

  3. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age

    Time frame: Day 0

    The age of participants will be noted in years

  4. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age

    Time frame: Day 0

    The age of participants will be noted in years

  5. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis

    Time frame: Day 0

    The diuresis of participants will be measured in millilitres

  6. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis

    Time frame: Month 1

    The diuresis of participants will be measured in millilitres

  7. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis

    Time frame: Day 0

    The diuresis of participants will be measured in millilitres

  8. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis

    Time frame: Month 1

    The diuresis of participants will be measured in millilitres

  9. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure

    Time frame: Day 0

    The blood pressure of participants will be noted

  10. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure

    Time frame: Month 1

    The blood pressure of participants will be noted

  11. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure

    Time frame: Day 0

    The blood pressure of participants will be noted

  12. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure

    Time frame: Month 1

    The blood pressure of participants will be noted

  13. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate

    Time frame: Day 0

    The heart rate of participants will be noted

  14. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate

    Time frame: Month 1

    The heart rate of participants will be noted

  15. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate

    Time frame: Day 0

    The heart rate of participants will be noted

  16. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate

    Time frame: Month 1

    The heart rate of participants will be noted

  17. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors

    Time frame: Day 0

    Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted

  18. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors

    Time frame: Month 1

    Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted

  19. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors

    Time frame: Day 0

    Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted

  20. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors

    Time frame: Month 1

    Cardiovascular risk factors (hypertension, diabetes, dyslipidemia, heredity) will be noted

  21. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history

    Time frame: Day 0

    The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.

  22. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history

    Time frame: Month 1

    The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.

  23. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history

    Time frame: Day 0

    The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.

  24. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history

    Time frame: Month 1

    The history and etiology of the heart disease (ischemic dilated, rhythmic, valvular, toxic, alcoholic) will be noted.

  25. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction

    Time frame: Day 0

    The Left ventricle Ejection Fraction will be measured as a %.

  26. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction

    Time frame: Month 1

    The Left ventricle Ejection Fraction will be measured as a %.

  27. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction

    Time frame: Day 0

    The Left ventricle Ejection Fraction will be measured as a %.

  28. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction

    Time frame: Month 1

    The Left ventricle Ejection Fraction will be measured as a %.

  29. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage

    Time frame: Day 0

    The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.

  30. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage

    Time frame: Month 1

    The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.

  31. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage

    Time frame: Day 0

    The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.

  32. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage

    Time frame: Month 1

    The stage of renal insufficiency (urea, creatinine, Calcium-Dependent Protein Kinase clearance) will be measured.

  33. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage

    Time frame: Day 0

    The New York Heart Association stage will be noted

  34. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage

    Time frame: Month 1

    The New York Heart Association stage will be noted

  35. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage

    Time frame: Day 0

    The New York Heart Association stage will be noted

  36. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage

    Time frame: Month 1

    The New York Heart Association stage will be noted

  37. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure

    Time frame: Day 0

    The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted

  38. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure

    Time frame: Month 1

    The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted

  39. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure

    Time frame: Day 0

    The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted

  40. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure

    Time frame: Month 1

    The type of heart failure (congestive heart failure/left heart failure/right heart failure) will be noted

  41. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy

    Time frame: Day 0

    The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.

  42. Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy

    Time frame: Month 1

    The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.

  43. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy

    Time frame: Day 0

    The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.

  44. Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy

    Time frame: Month 1

    The therapy given (Beta-blocker, ACE inhibitor, ARB2, Anti aldosterone, diuretics) and dosage, Implantable cardiac device, pacemaker will be noted.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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).

Acronym: JECICA2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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