Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- 24-h Holter reporting
研究概览
简要总结
The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.
详细描述
This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.
排除标准
- •Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
- •Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period
- •History of life-threatening ventricular arrhythmia within 3 months.
- •History of Torsades de Pointes (TdP) or family history of long QT-syndrome
- •Heart rate (HR) < 50 or > 100 bpm.
- •Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure (DBP) > 100 mmHg.
- •Ventricular tachycardia.
- •Episode of atrial fibrillation or atrial flutter lasting > 60 seconds.
- •Second or third degree atrioventricular (AV) block.
- •Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l.
- •Creatinine > 170 µmol/l or on dialysis.
- •Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.
研究组 & 干预措施
A
Levosimendan
干预措施: Levosimendan (Drug)
B
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
24-h Holter reporting
时间窗: every 2 weeks
次要结局
未报告次要终点