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
- Bad Nauheim, Berlin, Essen, Goettingen, Heidelberg, Jena, and Wuerzburg, GermanySee the 7 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic hypertrophic cardiomyopathy who finished an earlier Cytokinetics trial of aficamten. It collects long-term safety data.
- Age
- 18 Years to 85 Years
- Sex
- All sexes can join.
- Disease stage
- Symptomatic hypertrophic cardiomyopathy (HCM), with LVEF of 55% or higher at the screening visit.
- Earlier treatment
- Must have completed a Cytokinetics trial investigating aficamten. Treatment with mavacamten within 56 days before dosing is not allowed without approval from the Medical Monitor.
- Biomarker or test result
- LVEF ≥ 55% at the Screening Visit.
Main reasons for not taking part
- Mavacamten treatment within 56 days before dosing, unless the Medical Monitor approved joining
- Another investigational drug or device study, or an investigational drug less than 1 month (or 5 half-lives, whichever is longer) before screening
- New atrial fibrillation needing rhythm treatment less than 30 days before screening, since the earlier aficamten trial
- Septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the earlier aficamten trial
- Confirmed LVEF below 40% with a dose interruption in an earlier aficamten study, or an ICD placed within 30 days before screening
Read by machine on 9 November 2026.
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 Germany
- Kerckhoff-Klinik GmbHBad Nauheim, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking 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.