EUCTR2018-001233-40-FR进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects with Heart Failure with Reduced Ejection Fraction and Decreased Exercise Tolerance - METEORIC-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
- 270
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
- •? Male or female, = 18 to = 85 years of age
- •? History of chronic HF, defined as requiring continuous treatment with medications for HF for a minimum of 3 months before screening
- •? NYHA class II or III at screening
- •? Left ventricular ejection fraction = 35%
- •? On maximally tolerated HF SoC therapies consistent with regional clinical practice guidelines, if not contraindicated and according to investigator judgment of the subject’s clinical status. Beta blocker dose must be stable for 30 days prior to randomization.
- •? NT-proBNP level = 200 pg/mL
- •? Peak VO2 = 75% of the predicted normal value with RER = 1.05 on a screening CPET, confirmed by a CPET core laboratory
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •? Paroxysmal atrial fibrillation or flutter documented within the previous 6 months, direct-current (DC) cardioversion or ablation procedure for atrial fibrillation within 6 months, or plan to attempt to restore sinus rhythm within 6 months of randomization. Subjects with persistent atrial fibrillation and no sinus rhythm documented in the prior 6 months are permitted.
- •? Symptomatic bradycardia, second-degree Mobitz type II, or third-degree heart block without a pacemaker.
- •? Ongoing or planned enrollment in cardiac rehabilitation.
- •? Requires assistance to walk or use of mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable if the subject is deemed capable of performing CPET.
- •? Major medical event or procedure within 3 months prior to randomization, including: hospitalization, surgery, renal replacement therapy or cardiac procedure. This includes episodes of decompensated HF that require IV HF treatment.
- •? At screening: Resting systolic BP > 140 mmHg or < 85 mmHg, or diastolic BP > 90 mmHg (mean of triplicate readings); Resting heart rate > 90 beats per minute, or < 50 beats per minute (mean of triplicate readings); Room air oxygen saturation < 90%; Hemoglobin <10.0 g/dL; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (by the modified Modification of Diet in Renal Disease equation); Hepatic impairment defined by a total bilirubin (TBL) = 2 × the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 × ULN. Patients with documented Gilbert syndrome and TBL = 2 × ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
- •? Significant adverse finding during CPET at screening that precludes safe participation in the study, per investigator
- •? Male subject with a female partner of childbearing potential and not willing to inform his partner of his participation in this clinical study.
- •? Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with investigational product (IP; OM or placebo) or within 5 days after the end of treatment with IP.
研究者
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