Biomarkers and Therapeutic Modelisation in Heart Failure (BIOMIC)
Home-based Assessment of Plasma Volume, Serum Potassium and Renal Function Variations in Patients With Heart Failure and Low Left Ventricular Ejection Fraction: Pilot Study BIOMIC. Biomarkers and Therapeutic Modelisation in Heart Failure
The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial encouraging results. Decongestion is one of the main objectives in Congestive HF, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. These three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive HF.
Main objective :
To assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated HF, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (ABOTT iSTAT).
Secondary objectives :
- to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by Istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations.
- bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Nancy、法国、54500
- 招聘中
- Brabois Hospital
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接触：
- Patrick Rossignol
- 电话号码：+33383157320
- 邮箱：p.rossignol@chu-nancy.fr
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接触：
- Faiez Zannad
- 电话号码：+33383157320
- 邮箱：f.zannad@chu-nancy.fr
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首席研究员：
- Patrick Rossignol
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副研究员：
- Faiez Zannad
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副研究员：
- Daniela Dobre
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副研究员：
- Jean Marc BOIVIN
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副研究员：
- Arnaud OLIVIER
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years old or over
- Patients with heart failure and FE ≤ 45% hospitalized for decompensated heart failure
Exclusion Criteria:
- GFR < 30 ml/min/1.73 m2 as estimated by the abbreviated MDRD formula
- Pregnancy and lactation
- Participation in other investigational trials
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
合作者和调查者
调查人员
- 研究主任：Patrick Rossignol、Brabois Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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