Long-term safety study of aficamten in adults with hypertrophic cardiomyopathy
Studies long-term safety of aficamten in adults with a heart thickening disease.
Plain-language title generated from the registry record
Registry title: Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Key facts
- Where
- Florence, Milan, Naples, Pisa, Rome, San Donato Milanese, and Trieste, ItalySee the 7 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04848506, who can take part
Where in Italy
- Careggi University HospitalFlorence, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Fondazione Toscana Gabriele MonasterioPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cytokinetics
- Trial code
- NCT04848506EU 2023-508963-58-00
- Record updated
- 13 October 2026
- Original description
The purpose of this study is to collect long-term safety and tolerability data for aficamten.Read full original descriptionShow less
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Inclusion: Completion of a Cytokinetics trial investigating aficamten; LVEF ≥ 55% at the Screening Visit.
Exclusion: 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 aficamten 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); History of implantable ICD placement within 30 days prior to screening; Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten.