EUCTR2016-002299-28-ES进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction - GALACTIC-HF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 8,232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject has provided informed consent
- •Male or female, = 18 to = 85 years of age
- •History of chronic HF
- •LVEF = 35%
- •NYHA class II to IV
- •Managed with HF SoC therapies consistent with regional clinical practice guidelines
- •Current hospitalization with primary reason of HF or prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening
- •BNP level = 125 pg/mL or an NT-proBNP level = 400 pg/mL at most recent screening assessment (for subjects with atrial fibrillation, the cut off levels are: BNP = 375 pg/mL or NT proBNP = 1200 pg/mL)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7457
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 828
排除标准
- •Inability to swallow study medication tablet
- •Receiving mechanical hemodynamic support or mechanical ventilation = 7 days prior to randomization
- •Receiving IV inotropes or IV vasopressors = 3 days prior to randomization
- •Receiving IV diuretics or IV vasodilators, or supplemental oxygen therapy = 12 hours prior to randomization
- •Acute coronary syndrome, stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 3 months prior to randomization
- •Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- •Routinely scheduled outpatient intravenous infusions for HF (eg, inotropes, vasodilators, diuretics) or routinely scheduled ultrafiltration
- •Systolic blood pressure > 140 mmHg or < 85 mmHg, or diastolic blood pressure > 90 mmHg, or heart rate > 110 beats per minute, or < 50 beats per minute at screening
- •Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
研究者
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