Bisoprolol Plasma Residual Concentrations for the Optimization of Drug Management in Heart Failure With Mild to Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Bisoprolol residual plasma concentration by dose and renal function
研究概览
简要总结
This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.
详细描述
The clinical relevance of bisoprolol plasma residual concentration in the management of HF medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. The investigators will perform an observational study to answer this issue.
In this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. This study is a pilot study.
Participants will be consecutive ambulatory chronic heart failure patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. Participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Participants will be subsequently studied by renal function.
Patients will be followed at one year with the electronic health record of the CHU de Caen for clinical events.
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
- •Consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (LVEF < 50%) at the CHU de Caen
- •Aged 18 y.o. or older
- •With a stable heart failure (see exclusion criteria)
- •At the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment)
排除标准
- •Unstable HF, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including HF, new onset or worsening of HF or coronary artery disease symptoms
- •Patient refusing to participate
- •Patients with a non maximum tolerated dose of bisoprolol
- •Patients with ivabradine intakes
- •Body weight < 60kg or > 100kg
- •Severe liver insufficiency
- •Pregnancy
- •Liberty deprived patients
结局指标
主要结局
Bisoprolol residual plasma concentration by dose and renal function
时间窗: At the time of inclusion
Bisoprolol plasma residual concentrations will be performed by liquid chromatography with tandem mass spectrometry (LC-MS/MS) with simple precipitation of proteins with acetonitrile, as described by Liu et al. The quantification will be in positive mode by multiple reaction monitoring with the following transitions: 326 to 116 for bisoprolol and 256 to 167 for diphenhydramine (control). Bisoprolol concentrations will be expressed in µg/L.
次要结局
- Clinical parameters at the time of inclusion(At the time of inclusion)
- Biological assessment(At the time of inclusion)
- Clinical outcomes at one year(At one year follow-up)