An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM).

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

• Completion of a Cytokinetics study investigating aficamten. If unable to
complete a qualifying
study due to circumstances not related to compliance or safety, the Medical
Monitor may review and determine eligibility.
• LVEF >=55% at the Screening Visit

Exclusion Criteria

Exclusion Criteria
• 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. Other investigational procedures while
participating in this study are not permitted.
• Since completion of a previous study of aficamten has:
* Developed new-onset paroxysmal or permanent atrial fibrillation requiring
rhythm restoring treatment (e.g., direct-current cardioversion, ablation
procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may
re-screen after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30
days.
* Undergone septal reduction therapy (surgical myectomy or transcatheter
alcohol ablation).
• Has current obstructive coronary artery disease (>70% stenosis documented in
one or more arteries)
• Has moderate or severe aortic valve stenosis
• Had a confirmed LVEF <40% with an associated dose interruption during
participation in a prior study with aficamten. If data from the participant's
cohort has been unblinded, the patient may be considered for entry.
• History of syncope or sustained ventricular tachyarrhythmia with exercise
within 30 days prior to screening.
• History of appropriate ICD shock within 30 days prior to screening.
• Has received treatment with mavacamten.

Exclusion Criteria for CMR sub-study
• Inability to tolerate CMR
• Has an implantable cardioverter-defibrillator (ICD)
• Has a cardiac pacemaker

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of adverse events observed during dosing of CK-3773274 in patients<br /><br>with HCM Patient.<br /><br>Incidence of reported Adverse Events (AEs).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1 Incidence of serious adverse events<br /><br>2. Incidence of left ventricular ejection fraction (LVEF) < 50% observed during<br /><br>dosing of CK-3773274 in patients with HCM<br /><br>3. Long-term effects of CK-3773274 on left ventricular outflow tract gradient<br /><br>(LVOT G) in patients with oHCM</p><br>