CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM (SEQUOIA-HCM)
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|ClinicalTrials.gov Identifier: NCT05186818|
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : April 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Obstructive Hypertrophic Cardiomyopathy (oHCM)||Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg) Drug: Placebo to match CK-3773274||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction|
|Actual Study Start Date :||February 1, 2022|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: CK-3773274 up to 20 mg
Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 24 weeks
Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)
CK-3773274 tablets administered orally
Placebo Comparator: Placebo to match CK-3773274
Patients will receive placebo for up to 24 weeks
Drug: Placebo to match CK-3773274
Placebo administered orally
- Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET) [ Time Frame: Baseline to Week 24 ]Effect of CK-3773274 on exercise capacity in patients with symptomatic oHCM
- Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) [ Time Frame: Baseline to Week 12 and Week 24 ]Effect of CK-3773274 on patient health status
- Proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline to Week 12 and Week 24 ]Effect of CK-3773274 on NYHA Functional Classification
- Change in post-Valsalva left ventricular outflow tract gradients (LVOT-G) [ Time Frame: Baseline to Week 12 and Week 24 ]Effect of CK-3773274 on post-Valsalva LVOT-G
- Proportion of patients with post-Valsalva LVOT G <30 mmHg [ Time Frame: Baseline to Week 12 and Week 24 ]Effect of CK-3773274 on post-Valsalva LVOT-G
- Change in total workload during CPET [ Time Frame: Baseline to Week 24 ]Effect of CK-3773274 on exercise capacity
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- 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 <80% 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 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 requiring rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- Has received prior treatment with CK-3773274 or mavacamten.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186818
|Contact: Cytokinetics MDfirstname.lastname@example.org|
|Study Director:||Cytokinetics MD||Cytokinetics|
|Other Study ID Numbers:||
2021-003536-92 ( EudraCT Number )
|First Posted:||January 11, 2022 Key Record Dates|
|Last Update Posted:||April 26, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Obstructive Hypertrophic Cardiomyopathy
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases