Long-term safety study of aficamten in adults with hypertrophic cardiomyopathy
Studies long-term safety of aficamten in adults with a heart thickening disease.
Key facts
- Who runs it
- Cytokinetics
- Where
- Prague, CzechiaSee the siteAlso in 18 other countries, 142 sites
- Registry title
- Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
- Status
- Enrolling by invitation
- Phase
- Phase 2/3
- People taking part
- 900 people, planned
- Started
- 6 May 2021
- Expected to end
- Mar 2029
- Type of study
- Interventional
- Treatments tested
- Aficamten (5 - 20 mg)
- Record updated
- 13 October 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
Who cannot take part
- 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
Check if you might fit
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?
Where in Czechia
Also in 18 other countries, 142 sites
- Vseobecna fakultni nemocnice v PrazePrague, CzechiaTaking people
About the trial
What the trial wants to find out
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
The group in the trial
- AficamtenTreatment being tested
Participants in this arm take aficamten starting at the lowest prespecified dose and titrating up to their individual maximum tolerated dose. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic. After Week 48, the visits can be yearly if participants meet criteria.
Treatment: Aficamten (5 - 20 mg)
Results explained
A paper that names this trial, explained in plain words.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
- Plain-language title
- Long-term safety study of aficamten in adults with hypertrophic cardiomyopathyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04848506, who can take part
- Publications
- Long-term impact of aficamten on patient-reported outcome measures in obstructive hypertrophic cardiomyopathy: results from FOREST-HCM.European journal of heart failure, 2026
- Aficamten is associated with improvements in cardiac mechanics in obstructive hypertrophic cardiomyopathy: Results from FOREST-HCM.Progress in cardiovascular diseases, 2026
- Record updated
- 13 October 2026