Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Completion of a Cytokinetics trial investigating CK-3773274
* LVEF ≥55% at the Screening Visit

Exclusion Criteria:

* Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
* 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 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) since the completion of a prior trial of CK-3773274.
* Had a confirmed LVEF \<40% with an associated dose interruption during participation in a prior study with CK-3773274
* History of appropriate ICD shock within 30 days prior to screening

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/30/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Said Alsidawi, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available