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 - CY 6033

Cytokinetics Inc.0 个研究点目标入组 420 人开始时间: 2023年10月26日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Cytokinetics Inc.
入组人数: 420

研究概览入排标准研究者记录与标识符相似试验

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

•Between 18–85 years of age at screening, Body mass index < 40 kg/m2, Diagnosed with nHCM and has a screening echocardiogram with the following: • End-diastolic 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, New York Heart Association (NYHA) class II or III, Respiratory exchange ratio of = 1.00 at screening by CPET and predicted peak oxygen uptake (pVO2) of = 90% for age and sex, KCCQ-CSS score of = 30 and = 85, N-terminal prohormone brain natriuretic peptide (NT-proBNP) of: • = 300 pg/mL or = 900 pg/mL if in atrial fibrillation or atrial flutter OR • For Black participants, = 225 pg/mL or = 675 pg/mL if in atrial fibrillation or atrial flutter, Hemoglobin = 10 g/d

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, 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, 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, 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), 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 the following events with exercise within 3 months prior to screening • syncope, • symptomatic ventricular arrhythmia, or • sustained ventricular tachyarrhythmia

研究者

发起方

Cytokinetics Inc.

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