NCT01979614已完成2 期
A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-controlled Study to Evaluate the Effects of Intravenous Serelaxin Infusion on Micro- and Macrovascular Function in Patients With Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points
研究概览
简要总结
This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.
详细描述
double blind, randomized, parallel group, placebo controlled study
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥18 years of age, with body weight <160 kg.
- •Patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, PET or SPECT myocardial perfusion), or invasive coronary angiography or by CT coronary angiography at any point in time in patients with or without mild left ventricular systolic dysfunction (LVSD)
排除标准
- •Previous treatment with serelaxin (also known as: RLX030, relaxin)
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment.
- •Current or planned dialysis.
- •Impaired renal function during screening defined as an estimated glomerular filtration rate (eGFR) at screening and prior to treatment of <30 mL/min/1.73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation due to potential issue with administration of GdDTPA used as the MRI contrast agent.
- •Sick-Sinus-Syndrome
- •Current or history of pulmonary edema, including suspected sepsis.
- •restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function)
- •Known significant valvular disease (including any of the following: severe aortic stenosis [AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis).
- •Clinical diagnosis of acute coronary syndrome (ACS) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
- •Troponin elevation and dynamics indicative of ACS at any time between screening and randomization.
- •Previous myocardial infarction within 3 months of screening
- •History of Coronary Artery Bypass Graft (CABG) surgery
- •Heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or any second or third degree AV block or atrial fibrillation/flutter with ventricular response of > 120 beats per minute)
- •Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease)
- •Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
研究组 & 干预措施
Serelaxin
Experimental
Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
干预措施: Serelaxin (Drug)
Placebo
Placebo Comparator
Placebo was administered by intravenous infusion for 48 hours
干预措施: Placebo (Other)
结局指标
主要结局
Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points
时间窗: baseline to Day 3
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
次要结局
- Change From Baseline in Aortic Distensibility Measured by MRI(At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion)
- Change From Baseline in Aortic Velocity(At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion)
- Change From Baseline in Augmentation Index Measured From Sphygmocor Device(Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion)
- Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance(Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion)
- Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis(Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion)
- Serum Concentration of Serelaxin(Day1, Day 2, Day 3 and Day 30 after the start of infusion)
- Serum Concentration of Antibodies to Serelaxin(From pre-dose on Day 1 until Day 30 after the start of drug infusion)
- Systemic Clearance of Serelaxin(From pre-dose on Day 1 until 48h after the start of drug infusion)
研究者
研究点 (1)
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