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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- 未提供
结局指标
主要结局
Evolution of the emerging biological marker copeptin in plasma samples from the conventional management group
时间窗: Month 1
Quantitative, pmol/L
Evolution of the emerging biological marker NGAL in plasma samples from the conventional management group.
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the Jet Echo group.
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker suPAR in plasma samples from the conventional management group.
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker NGAL in plasma samples from the Jet Echo group.
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker copeptin in plasma samples from the Jet Echo group
时间窗: Month 1
Quantitative, pmol/L
Evolution of the emerging biological marker sST2 in plasma samples from the Jet Echo group.
时间窗: 1 Month
Quantitative, ng/mL
Evolution of the emerging biological marker sST2 in plasma samples from the conventional management group.
时间窗: 1 Month
Quantitative, ng/mL
Evolution of the emerging biological marker chromogranin in plasma samples from the Jet Echo group
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker chromogranin in plasma samples from the conventional management group
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the Jet Echo group.
时间窗: Month 1
Quantitative, ng/mL
Evolution of the emerging biological marker cystatin in plasma samples from the conventional management group.
时间窗: Month 1
Quantitative, ng/mL
次要结局
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Sex(Day 0)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Age(Day 0)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: heart rate(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: blood pressure(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: history(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Left ventricle Ejection Fraction(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: renal insufficiency stage(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Sex(Day 0)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Diuresis(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: heart rate(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Age(Day 0)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Diuresis(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: blood pressure(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: risk factors(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: history(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: New York Heart Association stage(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: risk factors(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Left ventricle Ejection Fraction(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: renal insufficiency stage(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: New York Heart Association stage(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of heart failure(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of heart failure(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the conventional management group: Type of therapy(Month 1)
- Correlation between emerging biomarkers and clinical symptomatology in the Jet Echo group: Type of therapy(Month 1)