EUCTR2021-003536-92-PL进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 282
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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:
- •a. Has LV hypertrophy and 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 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.
- •- New York Heart Association (NYHA) Functional Class II or III at screening
- •- Hemoglobin =10 g/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 a 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
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).
- •a) Moderate-severe valvular aortic stenosis.
- •b) 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 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.
- •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.
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