CTIS2023-504809-37-00招募中1 期
A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - CY 6032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 170
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 65+（—）
- 性别
- All
入选标准
- •Males and females between 18 to 85 years of age, inclusive, at the signing of informed consent, Body mass index < 35 kg/m2, Qualification of BMI for study eligibility is only required at the participant’s first screening visit., Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography: a. Has LV hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and b. Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory: • = 15 mm in one or more myocardial segments OR • = 13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM, KCCQ score =90 at Screening Visit 2, Has a screening echocardiogram with the following as determined by the echocardiography core laboratory: a. Resting LVOT-G > 30 mm Hg and/or post-Valsalva LVOT-G = 50 mmHg at screening AND b. LVEF = 60% at screening, Hemoglobin = 10g/dL at screening, Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks
排除标准
- •Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM, History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening, History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed., Current or recent (< 4 weeks prior to signing of informed consent) therapy with disopyramide, History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening, History of intolerance or medical contraindication to beta blocker therapy, Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten, Resting SBP of > 160 mmHg at the time of screening, Resting heart rate of > 100 beats per minute (bpm) at the time of screening, Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations), Significant valvular heart disease a. Moderate-severe valvular aortic stenosis or fixed subaortic obstruction b. Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment), Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis), History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy at any time during their clinical course, Documented room air oxygen saturation reading < 90% at screening, Planned septal reduction treatment that cannot be deferred during the trial period
研究者
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