A Phase 2/3 interventional study of Aficamten (5 - 20 mg) in Symptomatic Hypertrophic Cardiomyopathy (HCM), sponsored by Cytokinetics. Enrolling by invitation at 141 sites in 19 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Cytokinetics · Phase 2/3, Interventional, and Treatment
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 900 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Cytokinetics is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Since completion of a previous trial of aficamten has:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Aficamten (5 - 20 mg)
Aficamten tablets, 5-20 mg daily, administered orally. Participants may continue on Aficamten until end of treatment criteria defined in the protocol is met.
Incidence of adverse events observed during dosing of aficamten in patients with HCM
Patient incidence of reported Adverse Events (AEs)
Time frame: Baseline to End of study, up to 5 years
Incidence of serious adverse events observed during dosing of aficamten in patients with HCM
Patient incidence of reported Serious Adverse Events (SAEs)
Time frame: Baseline to End of study, up to 5 years
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM
Patient incidence of reported LVEF \<50%
Time frame: Baseline to End of study, up to 5 years
Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with obstructive Hypertrophic Cardiomyopathy (oHCM)
Peak LVOT-G at rest; applicable only to patients with oHCM
Time frame: Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on resting LVOT-G
Proportion of patients with resting LVOT-G \< 30 mmHg; applicable only to patients with oHCM
Time frame: Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on post Valsalva LVOT-G
Proportion of patients with post-Valsalva LVOT-G \< 50 mmHg; applicable only to patients with oHCM
Time frame: Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on post Valsalva LVOT-G
Proportion of patients with post-Valsalva LVOT-G \< 30 mmHg; applicable only to patients with oHCM
Time frame: Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on left ventricular ejection fraction (LVEF) and post-Valsalva LVOT-G
Proportion of patients with LVEF ≥ 50%, resting LVOT-G \< 30 mmHg, and post-Valsalva LVOT-G \< 50 mmHg; applicable only to patients with oHCM
Time frame: Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on time to first resting LVOT-G < 30 mmHg through last follow-up
Applicable only to patients with oHCM
Time frame: Time to the following event through last follow-up, up to 5 years
Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up
Applicable only to patients with oHCM
Time frame: Time to the following event through last follow-up, up to 5 years
Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up
Applicable only to patients with oHCM
Time frame: Time to the following event through last follow-up, up to 5 years
Long-term effects of aficamten on time to first LVEF ≥ 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up
Applicable only to patients with oHCM
Time frame: Time to the following event through last follow-up, up to 5 years
Change from baseline values in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline to end of collection, up to 5 years
Change from baseline values in high sensitivity cardiac troponin I (hs-cTnI)
Time frame: Baseline to end of collection, up to 5 years
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Baseline to end of collection, up to 5 years
Showing the first 100 of 141 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Aficamten
Cardiomyopathy, Hypertrophic →