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Myosin Inhibitor

CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg) for Hypertrophic Cardiomyopathy (SEQUOIA-HCM Trial)

Phase 3
Waitlist Available
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12 and week 24
Awards & highlights

SEQUOIA-HCM Trial Summary

This trial will test a new drug, aficamten, to see if it is effective and safe in treating adults with a heart condition called hypertrophic cardiomyopathy.

Eligible Conditions
  • Obstructive Hypertrophic Cardiomyopathy

SEQUOIA-HCM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET)
Secondary outcome measures
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Change in post-Valsalva left ventricular outflow tract gradients (LVOT-G)
Change in total workload during CPET
+3 more

SEQUOIA-HCM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CK-3773274 up to 20 mgExperimental Treatment1 Intervention
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
Group II: Placebo to match CK-3773274Placebo Group1 Intervention
Patients will receive placebo for up to 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)
2022
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

CytokineticsLead Sponsor
40 Previous Clinical Trials
15,026 Total Patients Enrolled
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.Industry Sponsor
8 Previous Clinical Trials
1,254 Total Patients Enrolled
Cytokinetics MDStudy DirectorCytokinetics
2 Previous Clinical Trials
492 Total Patients Enrolled

Media Library

Hypertrophic Cardiomyopathy Research Study Groups: CK-3773274 up to 20 mg, Placebo to match CK-3773274

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this clinical trial turn away patients who are over 30 ?

"Following the age guidelines set in the inclusion criteria, potential patients must be between 18 and 85 years old."

Answered by AI

Are there any remaining slots available for participants in this research?

"The study, which is looking for participants, is still open according to the information available on clinicaltrials.gov. The listing was first posted on February 1st, 2022 and was last updated on October 23rd of the same year."

Answered by AI

How many people are eligible to sign up for this test program?

"In order to properly conduct this research, 270 participants that meet the required criteria must be recruited. Cytokinetics, the sponsor, will manage the trial from various locations - such as Ascension St. John Clinical Research Institute in Tulsa, Oklahoma and MedStar Medical Group Cardiology at Union Memorial in Baltimore, Maryland."

Answered by AI

At what doses has CK-3773274 been linked with harmful side effects in patients?

"CK-3773274 has undergone Phase 3 clinical trials, meaning that there is some evidence of efficacy and multiple rounds of data supporting safety. Thus, our team has rated its safety at a 3."

Answered by AI

At how many healthcare facilities is this research project currently taking place?

"With 34 locations recruiting patients for this study, there is likely a site near you. Some of the locations include Tulsa, Baltimore and Dallas. If you choose to participate in this study, it is best to select a location close to you to reduce travel."

Answered by AI

Could I possibly take part in this experiment?

"The ideal candidate for this clinical trial would have cardiomyopathy, be hypertrophic, and between 18 and 85 years old. Currently, the trial is looking to enroll 270 people."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Houston Methodist Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM (SEQUOIA-HCM)
2022. "Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM (SEQUOIA-HCM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05186818.
~89 spots leftby Apr 2025
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