NL-OMON51492尚未招募2 期
An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM). - Cytokinetics CY 6022 (REDWOOD-OLE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 9
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
- •Completion of a Cytokinetics study investigating aficamten. If unable to
- •complete a qualifying
- •study due to circumstances not related to compliance or safety, the Medical
- •Monitor may review and determine eligibility.
- •LVEF >=55% at the Screening Visit
排除标准
- •Exclusion Criteria
- •Has participated in another investigational device or drug study or received
- •an investigational device or drug <1 month (or 5 half-lives for drugs,
- •whichever is longer) prior to screening. Other investigational procedures while
- •participating in this study are not permitted.
- •Since completion of a previous study of aficamten has:
- •* Developed new-onset paroxysmal or permanent atrial fibrillation requiring
- •rhythm restoring treatment (e.g., direct-current cardioversion, ablation
- •procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may
- •re-screen after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30
- •* Undergone septal reduction therapy (surgical myectomy or transcatheter
- •alcohol ablation).
- •Has current obstructive coronary artery disease (>70% stenosis documented in
- •one or more arteries)
- •Has moderate or severe aortic valve stenosis
- •Had a confirmed LVEF <40% with an associated dose interruption during
- •participation in a prior study with aficamten. If data from the participant's
- •cohort has been unblinded, the patient may be considered for entry.
- •History of syncope or sustained ventricular tachyarrhythmia with exercise
- •within 30 days prior to screening.
- •History of appropriate ICD shock within 30 days prior to screening.
- •Has received treatment with mavacamten.
- •Exclusion Criteria for CMR sub-study
- •Inability to tolerate CMR
- •Has an implantable cardioverter-defibrillator (ICD)
- •Has a cardiac pacemaker
研究者
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