A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The change of NT-proBNP level
研究概览
简要总结
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
详细描述
The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Severe aortic stenosis
- •Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
- •Aortic peak velocity ≥ 4m/s;
- •Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2
- •Cardiac dysfunction
- •LVEF≤50% (estimated by Simpson)
- •NT-proBNP≥1500ng/L；
- •Symptoms of dyspnea and fatigue when at rest or after slight exertion (New York Heart Association ≥ Ⅲ -Ⅳ)
- •Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability
排除标准
- •Decompensated acute cardiac failure due to hemodynamic instability
- •A historty of torsade de points ventricular tachycardia
- •Known allergic reaction or sensitivity to Levosimendan or excipients
- •Received levosimendan within 1 week prior to the planned clinical trial
- •Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
- •Systolic blood pressure < 90mmHg at baseline
- •Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m
- •Unable to participate in study for being critically ill asssed by clinicians
- •Other concomitant severe morbidities leading to poor prognosis and decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year.
研究组 & 干预措施
Levosimendan
Levosimendan 0.1µg/kg/min will last for 24h after the valve is released.
干预措施: Levosimendan (Drug)
Placebo
5% glucose 0.1µg/kg/min administration will continue for 24h after the valve is released.
干预措施: Placebo (Other)
结局指标
主要结局
The change of NT-proBNP level
时间窗: day 1, day 3, day 5, month 1 and month 3
次要结局
- The change of CK-MB(day 1, day 3, day 5, month 1 and month 3)
- The change of c-TnI(day 1, day 3, day 5, month 1 and month 3)
- The change of left ventricular ejection fraction(day 1, day 3, day 5, month 1 and month 3)
- The change of left ventricular end-diastolic diameter(day 1, day 3, day 5, month 1 and month 3)
- The number of patients in need of secondary intra-operative vasoactive-inotropic substances(Peri-operation)
- The incidence of postoperative kidney injury(day 1, day 3, day 5, month 1 and month 3)
研究者
Jianhui Wang
Principle Investigator and Clinical professor
China National Center for Cardiovascular Diseases