jRCT2031250066招募中不适用
A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy. (A study of aficamten in adults with symptomatic non-obstructive hypertrophic cardiomyopathy (ACACIA-HCM))
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
入选标准
- •Between 18-85 years of age
- •Body mass index < 40 kg/m2
- •Diagnosed with nHCM and has a screening echocardiogram with the following:
- •End-diastolic left ventricular (LV) wall thickness:
- •>=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 AND
- •Resting LVOT-G < 30 mmHg AND Valsalva LVOT-G < 50 mmHg AND
- •LVEF >= 60%
- •Participants with a history of intracavitary obstruction are eligible.
- •NYHA class II or III
- •Respiratory exchange ratio of >= 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) <= 90% for age and sex
- •KCCQ-CSS score of >= 30 and <= 85
- •NT-proBNP of:
- •NT-pro BNP >= 300 pg/mL or NT-proBNP >= 900 pg/mL if in atrial fibrillation or atrial flutter OR
- •For Black participants, an NT-pro BNP >= 225 pg/mL or NT-proBNP >= 675 pg/mL if in atrial fibrillation or atrial flutter
排除标准
- •Significant valvular heart disease (per Investigator judgment)
- •Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
- •Moderate or severe mitral regurgitation
- •Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (e.g, Noonan syndrome, Fabry disease, amyloidosis)
- •Known current unrevascularized coronary artery stenosis of >= 70% or documented history of myocardial infarction.
- •History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
- •Inability to exercise on a treadmill or bicycle (e.g., orthopedic limitations)
- •Documented room air oxygen saturation reading < 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
- •History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
- •History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
- •Screening diastolic blood pressure >= 100 mmHg
- •Received prior treatment with aficamten
- •Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
- •Undergone septal reduction therapy < 6 months prior to screening
- •Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
- •Paroxysmal or permanent atrial fibrillation is excluded only if:
- •rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required <= 3 months prior to screening
- •rate control and anticoagulation have not been achieved for at least 3 months prior to screening.
研究者
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