NL-OMON54001已完成3 期
A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction - Cytokinetics CY 6031
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
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
- •Males and females between 18 and 85 years of age, inclusive, at screening.
- •Body mass index <35 kg/m^2.
- •Diagnosed with HCM per the following criteria: * Has LV hypertrophy and
- •non-dilated LV chamber in the absence of other cardiac disease and
- •* Has an end-diastolic LV wall thickness as measured by the echocardiography
- •core laboratory of: • >=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
- •Has resting LVOT-G >=30 mmHg and post-Valsalva LVOT G >=50 mmHg during
- •screening as determined by the echocardiography core laboratory.
- •LVEF >=60% at screening as determined by the echocardiography core laboratory.
- •NYHA Functional Class II or III at screening.
- •Hemoglobin >=10g/dL at screening.
- •Respiratory exchange ratio (RER) >=1.05 and pVO2 <=90% predicted on the
- •screening CPET per the core laboratory.
- •Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have
- •been on stable doses for >6 weeks prior to randomization and anticipate
- •remaining on the same medication regimen during the trial. Patients treated
- •with disopyramide must also be concomitantly treated with a beta blocker and/or
- •calcium channel blocker
排除标准
- •Known or suspected infiltrative, genetic or storage disorder causing cardiac
- •hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- •Significant valvular heart disease (per investigator judgment).
- •* Moderate-severe valvular aortic stenosis.
- •* Moderate-severe mitral regurgitation not due to systolic anterior motion of
- •the mitral valve.
- •History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at
- •any time during their clinical course.
- •Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations).
- •Has been treated with septal reduction therapy (surgical myectomy or
- •percutaneous alcohol septal ablation) or has plans for either treatment during
- •the trial period.
- •Documented paroxysmal atrial fibrillation during the screening period.
- •Paroxysmal or permanent atrial fibrillation requiring is only excluded IF:
- •- rhythm restoring treatment (eg, direct-current cardioversion, atrial
- •fibrillation ablation procedure, or antiarrhythmic therapy) has been required
- •<=6 months prior to screening. (This exclusion does not apply if atrial
- •fibrillation has been treated with anticoagulation and adequately
- •rate-controlled for >6 months.)
- •-rate control and anticoagulation have not been achieved for at least 6 months
- •prior to screening
- •History of syncope or sustained ventricular tachyarrhythmia with exercise
- •within 6 months prior to screening.
- •Has received prior treatment with CK-3773274 or 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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