Status:
COMPLETED
Aficamten vs Placebo in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (SEQUOIA-HCM)
Lead Sponsor:
Cytokinetics
Collaborating Sponsors:
Corxel Pharmaceuticals
Conditions:
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 trac...
Detailed Description
CY 6031 was a Phase 3, randomized, placebo-controlled, double-blind, multi-center trial in participants with symptomatic oHCM. Eligible participants were randomized in a 1:1 ratio to receive aficamten...
Eligibility Criteria
Inclusion
- Key
- Males and females between 18 and 85 years of age, inclusive, at screening.
- Body mass index \<35 kg/m2.
- Diagnosed with HCM per the following criteria:
- Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and
- Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of:
- ≥15 mm in one or more myocardial segments OR
- ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
- Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory.
- LVEF ≥60% at screening as determined by the echocardiography core laboratory.
- NYHA Functional Class II or III at screening.
- Hemoglobin ≥10g/dL at screening.
- Respiratory exchange ratio (RER) ≥1.05 and pVO2 ≤90% predicted on the screening CPET per the core laboratory.
- Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for \>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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2023
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT05186818
Start Date
February 1 2022
End Date
December 18 2023
Last Update
February 27 2025
Active Locations (114)
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1
Alaska Heart and Vascular Institute
Anchorage, Alaska, United States, 99508
2
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037
3
Cedars-Sinai Medical Center - Smidt Heart Institute Clinic
Los Angeles, California, United States, 90048
4
University of California San Francisco
San Francisco, California, United States, 94143