Phase 3
N=282
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Bottom Line
View on ClinicalTrials.gov: NCT05186818 ↗Enrolled (actual)
282
Serious AEs
7.4%
Results posted
Mar 2026
Primary outcome: Primary: Change From Baseline in pVO2 at Week 24 — 1.76; 0.02 mL/kg/min — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg) (Drug); Placebo to match aficamten (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cytokinetics
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in pVO2 at Week 24 |
1.76; 0.02 | <0.0001 sig |
| SECONDARY Change From Baseline in KCCQ-CSS at Week 24 |
11.6; 4.3 | <0.0001 sig |
| SECONDARY Change From Baseline in KCCQ-CSS at Week 12 |
11.1; 4.0 | <0.0001 sig |
| SECONDARY Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24 |
83; 34 | <0.0001 sig |
| SECONDARY Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12 |
69; 25 | <0.0001 sig |
| SECONDARY Change From Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G) at Week 24 |
-48; 2 | <0.0001 sig |
| SECONDARY Change From Baseline in Valsalva LVOT-G at Week 12 |
-46; 3 | <0.0001 sig |
| SECONDARY Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 24 |
70; 5 | <0.0001 sig |
| SECONDARY Proportion of Participants With Valsalva LVOT G <30 mmHg at Week 12 |
74; 8 | <0.0001 sig |
| SECONDARY Duration of SRT Eligibility During the 24-week Treatment Period for Participants Who Were SRT Eligible at Baseline |
35.3; 113.4 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 24 in Total Workload During CPET |
13.4; 1.2 | <0.0001 sig |
Summary
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
Eligibility Criteria
Key Inclusion Criteria
- Males and females between 18 and 85 years of age, inclusive, at screening.
- Body mass index 6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.
Key Exclusion Criteria
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- Significant valvular heart disease (per investigator judgment).
- Moderate-severe valvular aortic stenosis.
- Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve.
- History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time during their clinical course.
- Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations).
- Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period.
- Documented paroxysmal atrial fibrillation during the screening period.
- Paroxysmal or permanent atrial fibrillation is only excluded IF:
- rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤6 months prior to screening.
- rate control and anticoagulation have not been achieved for at least 6 months prior to screening.
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- Has received prior treatment with CK-3773274 or mavacamten.
Data sourced from ClinicalTrials.gov (NCT05186818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.