ACTIVE_NOT_RECRUITING

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

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Conditions

Symptomatic Non-Obstructive Hypertrophic CardiomyopathyCK-3773274CK-274AficamtennHCMACACIA-HCMACACIA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

Official Title

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Quick Facts

Study Start:2023-08-30
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06081894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18-85 years of age
  2. * Body mass index \< 40 kg/m2
  3. * Diagnosed with nHCM and has a screening echocardiogram with the following:
  4. * End-diastolic left ventricular (LV) wall thickness:
  5. * ≥ 15 mm in one or more myocardial segments OR
  6. * ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM AND
  7. * Resting LVOT-G \< 30 mmHg AND Valsalva LVOT-G \< 50 mmHg AND
  8. * LVEF ≥ 60%
  9. * Participants with a history of intracavitary obstruction are eligible.
  10. * NYHA class II or III
  11. * Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex
  12. * KCCQ-CSS score of ≤ 85
  13. * NT-proBNP of:
  14. * NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR
  15. * For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter
  1. * Significant valvular heart disease (per Investigator judgment)
  2. * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
  3. * Moderate or severe mitral regurgitation
  4. * Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
  5. * Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.
  6. * History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy
  7. * Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
  8. * Documented room air oxygen saturation reading \< 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
  9. * History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
  10. * History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
  11. * Screening diastolic blood pressure ≥ 100 mmHg
  12. * Received prior treatment with aficamten
  13. * Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
  14. * Undergone septal reduction therapy \< 6 months prior to screening
  15. * Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
  16. * Paroxysmal or permanent atrial fibrillation is excluded only if:
  17. * rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening
  18. * rate control and anticoagulation have not been achieved for at least 3 months prior to screening.

Contacts and Locations

Principal Investigator

Cytokinetics MD
STUDY_DIRECTOR
Cytokinetics

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, 92037
United States
Keck Medical Center of USC (Outpatient Clinic)
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, 90048
United States
UCLA Medical Center Cardiovascular Clinic
Los Angeles, California, 90095
United States
University of California San Francisco
San Francisco, California, 94143
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Yale New Haven Hospital
New Haven, Connecticut, 06519
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale, Florida, 33308
United States
Investigational Drug Services, AdventHealth Orlando
Orlando, Florida, 32804
United States
Emory Clinic
Atlanta, Georgia, 30322
United States
Piedmont Heart Institute (CPET)
Fayetteville, Georgia, 30214
United States
The Queen's Medical Center-Punchbowl
Honolulu, Hawaii, 96813
United States
Northwestern University
Evanston, Illinois, 60208
United States
Ascension St. Vincent
Indianapolis, Indiana, 46260
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803
United States
Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
United States
NYU Langone Health
New York, New York, 10016
United States
Weill Cornell Medicine
New York, New York, 10021
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte, North Carolina, 28204
United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605-5601
United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, 37205
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Utah Health
Salt Lake City, Utah, 84132
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Inova Health Care Services
Falls Church, Virginia, 22042
United States
VCU Health Downtown Medical Campus
Richmond, Virginia, 23298
United States
Carilion Clinic Cardiology
Roanoke, Virginia, 24014
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Providence Sacred Heart Medical Center & Children's Hospital (CPET)
Spokane, Washington, 99204
United States
WVU Medicine
Morgantown, West Virginia, 26506
United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Cytokinetics

  • Cytokinetics MD, STUDY_DIRECTOR, Cytokinetics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-30
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-08-30
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • CK-3773274
  • CK-274
  • Aficamten
  • Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
  • nHCM
  • ACACIA-HCM
  • ACACIA

Additional Relevant MeSH Terms

  • Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy