An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Hypertrophic Cardiomyopathy,covid-19
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Age: Between 18 years - 85 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions
- Completion of a Cytokinetics study investigating CK-3773274
- Left ventricular ejection fraction = 55%
- Male patients are eligible to participate if they agree to the following during the study and for at least 10 weeks after the last dose of IP
- A female patient is eligible to participate if she is not pregnant, breastfeeding or planning to donate eggs, and is not a woman of childbearing potential OR Is a WOCBP and using a highly effective method of contraceptive
- Willing and able to complete all screening procedures
You may not be eligible for this study if the following are true:
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- Has received treatment with mavacamten
- Has participated in another investigational device or drug study or received an investigational device or drug <1 month (or 5 half-lives for drugs, whichever is longer) prior to screening
- Has any acute or serious comorbid condition (e.g., major infection or hematologic, oncologic, cardiac, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the site Principal Investigator/designee or Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
- Has developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment
- Has undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior study of CK-3773274
- Has moderate or severe aortic valve stenosis 09 December 2021
- Had a confirmed LVEF <40% with an associated dose interruption during CY 6021 or CY 6031
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
- History of ICD placement within 30 days prior to screening.
- Hypersensitivity to excipients in CK-3773274 Tablets, Film-Coated.
- Does not consent to participate in CMR sub-study
- Inability to tolerate CMR
- Has an implantable cardioverter-defibrillator (ICD)
- Has a cardiac pacemaker
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.