A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Cytokinetics, Inc.0 个研究点目标入组 60 人开始时间: 2019年12月20日最近更新: 2020年9月28日

适应症

试验速览

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•Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities (SoA).
•Males and females between 18 and 70 years of age at Screening.
•Body weight is =45 kg at Screening.
•Diagnosed with oHCM per the following criteria:
•Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease.
•Has minimal wall thickness =15 mm at time of initial diagnosis (minimal wall thickness =13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
•Adequate acoustic windows for echocardiography.
•Has LVOT-G during screening as follows:
•Resting gradient =50 mmHg
•Resting gradient =30 mmHg and <50 mmHg with post-Valsalva LVOT G =50 mmHg
•LVEF =60% at screening.
•New York Heart Association (NYHA) Class II or III at Screening.
•Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to Randomization and anticipate remaining on the same medication regimen during the study.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•Aortic stenosis or fixed subaortic obstruction.
•Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
•History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
•Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
•Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period.
•Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening.
•Documented atrial fibrillation during the Screening period.
•Paroxysmal atrial fibrillation or flutter requiring treatment (eg, anti-coagulation or antiarrhythmic therapy including disopyramide) documented within the 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 CK3773274 or is currently receiving mavacamten.

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