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History of Changes for Study: NCT05186818
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)
Latest version (submitted January 4, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 23, 2021 None (earliest Version on record)
2 February 26, 2022 Recruitment Status, Study Status and Contacts/Locations
3 March 7, 2022 Study Status and Contacts/Locations
4 April 1, 2022 Study Status and Contacts/Locations
5 April 15, 2022 Contacts/Locations and Study Status
6 April 25, 2022 Contacts/Locations and Study Status
7 May 13, 2022 Study Status and Contacts/Locations
8 June 2, 2022 Study Status and Contacts/Locations
9 June 13, 2022 Contacts/Locations and Study Status
10 June 16, 2022 Contacts/Locations and Study Status
11 June 22, 2022 Contacts/Locations and Study Status
12 July 5, 2022 Study Status and Contacts/Locations
13 July 20, 2022 Contacts/Locations and Study Status
14 July 29, 2022 Contacts/Locations and Study Status
15 August 9, 2022 Study Status and Contacts/Locations
16 August 22, 2022 Contacts/Locations and Study Status
17 August 29, 2022 Contacts/Locations and Study Status
18 September 8, 2022 Study Status and Contacts/Locations
19 October 3, 2022 Contacts/Locations and Study Status
20 October 11, 2022 Contacts/Locations and Study Status
21 October 23, 2022 Contacts/Locations and Study Status
22 December 6, 2022 Study Status and Contacts/Locations
23 December 13, 2022 Contacts/Locations and Study Status
24 January 6, 2023 Study Status and Contacts/Locations
25 January 31, 2023 Contacts/Locations and Study Status
26 February 17, 2023 Study Status and Contacts/Locations
27 March 9, 2023 Study Status and Contacts/Locations
28 April 13, 2023 Study Status and Contacts/Locations
29 April 24, 2023 Contacts/Locations and Study Status
30 July 20, 2023 Recruitment Status, Study Status, Contacts/Locations, Study Design, Eligibility and Outcome Measures
31 September 1, 2023 Study Status and Contacts/Locations
32 January 4, 2024 Recruitment Status, Study Status and Study Identification
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Study NCT05186818
Submitted Date:  December 23, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: CY 6031
Brief Title: 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)
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
Secondary IDs: 2021-003536-92 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2021
Overall Status: Not yet recruiting
Study Start: January 2022
Primary Completion: September 2023 [Anticipated]
Study Completion: September 2023 [Anticipated]
First Submitted: December 23, 2021
First Submitted that
Met QC Criteria:
December 23, 2021
First Posted: January 11, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
December 23, 2021
Last Update Posted: January 11, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Cytokinetics
Responsible Party: Sponsor
Collaborators: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
Detailed Description:
Open or close this module Conditions
Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
Keywords: Obstructive Hypertrophic Cardiomyopathy
oHCM
CK-3773274
CK-274
Aficamten
SEQUOIA-HCM
CY 6031
SEQUOIA
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 270 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
2. 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
3. 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
4. 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
5. Change in total workload during CPET
[ Time Frame: Baseline to Week 24 ]

Effect of CK-3773274 on exercise capacity
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Cytokinetics MD
Telephone: 650-624-2929
Email: medicalaffairs@cytokinetics.com
Study Officials: Cytokinetics MD
Study Director
Cytokinetics
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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