CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for CK-3773274

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect long-term safety and tolerability data for CK-3773274

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytokinetics

Criteria

Inclusion Criteria:

• Completion of a Cytokinetics trial investigating CK-3773274

• LVEF ≥55% at the Screening Visit

Exclusion Criteria:

• Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening

• Since completion of a previous trial of CK-3773274 has:

• Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 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 CY 6021

• Has been treated with drugs that have negative inotropic activity (except for beta- blockers, calcium channel blockers, or disopyramide) as monotherapy or in combination within 30 days prior to screening. Patients receiving treatment with disopyramide require approval from the medical monitor prior to enrollment.

• 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 within 3 months prior to screening