NL-OMON50612已完成3 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 - 20110203 - GALACTIC HF
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •- 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)
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
- •- Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
研究者
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