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 | NYU Langone Health

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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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Hypertrophic Cardiomyopathy
Age: Between 18 years - 70 years
Gender: Male or Female

Other Inclusion Criteria:
1. Males and females between 18 and 85 years of age at screening
2. Body weight is > = 45 kg at screening
3. Diagnosed with HCM
4. Participants 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
5. For Cohort 3: Participants must be taking disopyramide. Patients should have been on stable disopyramide doses for >4 weeks prior to screening and anticipate remaining on the same medication regimen during the study

You may not be eligible for this study if the following are true:

1. Aortic stenosis or fixed subaortic obstruction
2. Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM
3. History of LV systolic dysfunction
4. Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
5. Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period (
6. For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening
7. Paroxysmal atrial fibrillation or flutter documented during the screening period
8. Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) = < 6 months prior to screening
9. History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
10. Has received prior treatment with CK-3773274 or is currently receiving mavacamten
11. For Cohort 4: has any documented history of LVOT-G > = 30 mmHg at rest, with Valsalva, or with exercise