Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of rehospitalisations in patients with severe heart failure treated with 24-hour levosimendan infusions
研究概览
简要总结
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure.
Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system.
Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure.
Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.
详细描述
Heart failure affects 12% of the adult population and its frequency increases with age and affects 10% of people over 70 years old. Heart failure is characterized by high annual death rate reaching 17% and the percentage of rehospitalization at the level of 44% annually. In order to reduce morbidity and mortality rates in the case of heart failure, many diagnostic and therapeutic methods have been introduced over the last few years, however the prognosis for this medical condition is still unfavorable nonetheless.
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure.
Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. At the moment, there are numerous clinical trials aimed at improving the prognosis of patients with heart failure.
Levosimendan is a modern drug registered in the treatment of acute heart failure. In the current ESC guidelines for the treatment of patients with acute heart failure, levosimendan is mainly recommended for the group of patients chronically treated with beta-adrenolytics and in the treatment of a peri-infarction shock.
It is a substance with inotropic positive and vasodilating effects. It belongs to the group of drugs sensitizing contractile elements of a myocardium on calcium ions. In the clinical trials and meta-analyses, the safety profile of levosimendan is better in comparison to the classical pressure amines used in the treatment of acute heart failure: dobutamine and dopamine. Beneficial clinical effect of levosimendan is prolonged beyond the period of its direct use due to the active metabolites remaining in the bloodstream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 2 hospitalizations due to exacerbation of chronic heart failure with reduction of left ventricular ejection fraction (EF< 40%) during last 6 months, despite optimal heart failure treatment
排除标准
- •chronic kidney disease (GFR < 30)
- •severe liver damage (AT 5x > N, bilirubin >2,0 g/dl)
- •hypotonia
- •hypokalemia
- •HGB<10g/dl
- •severe aortic and mitral stenosis
- •tachycardia >100/min or atrial fibrillation with HR > 120/min
- •features of hypovolemia
- •levosimendan intolerance
- •acute infection
研究组 & 干预措施
Levosimendan
干预措施: Levosimendan (Drug)
结局指标
主要结局
Number of rehospitalisations in patients with severe heart failure treated with 24-hour levosimendan infusions
时间窗: 12 months
次要结局
- Change in quality of life in patients with severe heart failure treated with 24-hour levosimendan infusions.(from baseline up to 4 weeks during 6 months)
- Change in sodium in patients with severe heart failure treated with 24-hour: SF-36 questionnaire levosimendan infusions.(from baseline up to 4 weeks during 6 months)
- Change in NT-proBNP in patients with severe heart failure treated with 24-hour levosimendan infusions.(from baseline and up to 4 weeks during 6 months.)
- Change in kaldyum in patients with severe heart failure treated with 24-hour levosimendan infusions.(from baseline up to 4 weeks during 6 months)
- Change in troponin T in patients with severe heart failure treated with 24-hour levosimendan infusions.(from baseline and up to 4 weeks during 6 months.)
研究者
Małgorzata Dobosiewicz, PhD
Professor Grzegorz Grześk
Collegium Medicum w Bydgoszczy