NCT01188369终止4 期
Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- E/E'(Unitless)
研究概览
简要总结
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
详细描述
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
- Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
- Immediately before surgery
- After induction of anaesthesia and before "knife time" = start of surgery.
- At the end of surgery: Levosimendan infusion will stop.
- Approximately 4 hours after surgery immediately before extubation.
- Approximately 21 hours after surgery
- Approximately 96 hours after surgery (day 4)
- 6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for aortic valve replacement
- •EF > 45%
- •Left ventricular posterior wall > 12mm
- •Sinus rhythm
排除标准
- •Concomitant bypass operation
- •Severe mitral insufficiency
- •Active endocarditis
- •Insufficient ultrasound opportunity
- •Systolic blood pressure < 100 mmHg
- •moderate-severe renal failure
- •allergy to levosimendan
- •lack of patient consent Pregnancy or status of lactating
- •Fertile women who do not use relevant anticonception
研究组 & 干预措施
levosimendan
Experimental
infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation
干预措施: levosimendan (Drug)
Placebo
Placebo Comparator
Identical placebo
干预措施: placebo drug (Drug)
结局指标
主要结局
E/E'(Unitless)
时间窗: 4 hours before operation until 21 hour after operation
Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function
次要结局
- Isovolumetric Relaxation Time (IVRT) (s)(End of operation until approx. 4 hours after operation)
- Ejection Fraction (Per Cent)(End of operation until approx. 4 hours after operation)
- Cardiac Index (l/Min/m2)(4 hours after operation until 21 hours after operation)
- Central Venous Pressure (mmHg)(4 hours after operation until 21 hours after operation)
- Pulmonary Artery Pressures (mmHg)(4 hours after operation until 21 hours after operation)
- Systemic Arterial Pressure (mmHg)(4 hours after operation until 21 hours after operation)
- N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)(21 hours after operation until 96 hours after operation)
- Troponin T (ug/l)(21 hours after operation until 96 hours after operation)
- Lactate (mmol/l)(4 hours after operation until 21 hours after operation)
- Mixed Venous Oxygenation (Per Cent)(4 hours after operation until 21 hours after operation)
- E/A Ratio (Unitless)(At the end of operationon until approx 4 hours after operation)
- Regional Longitudinal Strain (Unitless)(96 hours after operation until 6 months after operation)
- Need for Conventional Inotropical Agents(From start of operation until 5 days after operation)
- Intravenous Fluid Requirement (l)(Within 24 hours from start of operation)
- Operation Time (Minutes)(From "knife start" until "knife end", approximately 3 hours)
- Time on Heart-lung Machine (Minutes)(From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour)
- Intubation Time (Minutes)(From intubation until extubation, approximately 6 hours)
- Postoperative Admission Time at Intensive Care Unit (Hours)(From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours)
- No. of Patients With Adverse Events(-4 hours until + 96 hours with respect to start of operation)
- No. of Patients With Adverse Event(4 hours before operation until approximately 1 hour before operation)
- No. of Patients With Adverse Event.(4 hours before operation until 1 hour before operation)
- Peak Systolic Velocity (m/s)(96 hours after operation until 6 months after operation)
- Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)(96 hours after operation until 6 months after operation)
- E/A-ratio (Unitless)(96 hours after operation until 6 months after operation)
- E'/A'-Ratio (Unitless)(96 hours after operation until 6 months after operation)
- Left Ventricular Rotation (Degrees)(96 hour after operation until 6 months after operation)
- Inflammatory Parameters(21 hours after operation until 96 hours after operation)
- Urine Clearance(from start of operation until 24 hours after operation)
- E/A-ratio (Transoesophageal)(from end of operation until approximately 4 hours after operation)
研究者
研究点 (1)
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