EUCTR2016-002299-28-SE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
- 8,285
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 at signing of informed consent
- •History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
- •LVEF = 35%, per subject’s most recent medical record, within 12 months prior to screening. The most recent qualifying LVEF must be at least 30 days
- •after any of the following, if applicable: 1) an event likely to decrease EF (eg, myocardial infarction, sepsis); 2) an intervention likely to increase EF
- •(eg, cardiac resynchronization therapy, coronary revascularization); or 3) the first ever presentation for HF.
- •NYHA class II to IV at most recent screening assessment
- •Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject’s clinical status
- •Oral SoC therapies for chronic HF (eg, beta blockers, renin-angiotensin-aldosterone system inhibitors) should be present, if not
- •contraindicated. Subjects enrolled during either HF hospitalization or early after HF hospitalization discharge can be reinitiating or titrating oral SoC chronic HF therapies at the same time of randomization with the goal of achieving optimized therapy on study.
- •Currently hospitalized with primary reason of HF OR one of the following events within 1 year to screening: 1) hospitalization with primary reason of
- •HF; 2) urgent visit to ED with primary reason of HF
- •B-type natriuretic peptide (BNP) level = 125 pg/mL or an NT-proBNP level = 400 pg/mL at most recent screening assessment (subjects receiving
- •angiotensin receptor-neprilysin inhibitor [ARNi] must use NT-proBNP assessment; for subjects in atrial fibrillation/flutter at screening, 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
- •Factors expected to interfere with the subject’s availability or ability to complete all protocol-required study visits or procedures, and/or to comply with
- •all required study procedures to the best of the subject and investigator’s knowledge (including ongoing substance abuse).
- •Inability to swallow study medication tablet (eg, swallowing disorders, feeding tubes)
- •Receiving mechanical hemodynamic support (eg, intra-aortic balloon pump counterpulsation), or invasive mechanical ventilation = 7 days prior to
- •randomization
- •Receiving IV inotropes (eg, dobutamine, milrinone, levosimendan) or IV vasopressors (eg, epinephrine, norepinephrine, dopamine, or vasopressin)
- •= 3 days prior to randomization
- •Receiving IV diuretics or IV vasodilators, supplemental oxygen therapy, or non-invasive mechanical ventilation (eg, bilevel positive airway pressure
- •[BiPAP] or continuous positive airway pressure [CPAP] = 12 hours prior to randomization (Note: the use of non-invasive ventilation for sleep disordered breathing is permitted)
- •Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack, major cardiac surgery or cardiac intervention (ie, implantation of cardiac closure devices, cardiac resynchronization therapy, or catheter ablation), percutaneous coronary intervention, or valvuloplasty/other cardiac valve repair or implantation within the 3 months prior to randomization
- •Insertion of other cardiac devices (eg, implantable cardioverter defibrillator, permanent pacemaker, monitoring devices) within 30 days prior to
- •randomization
- •Severe uncorrected valvular heart disease, hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
研究者
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