A Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cytokinetics
Study ID
NCT06081894
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Aficamten — DRUG
    Oral Tablet
  • Placebo — DRUG
    Oral Tablet

Study Details

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.

Key Dates

First listed
Oct 13, 2023
Start date
Aug 31, 2023
Status verified
Sep 2026
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aficamten
    Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks.
  • Placebo Comparator: Placebo
    Participants in this arm will receive placebo, for up to 72 weeks.

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) [ Time Frame: Baseline to Week 36 ]

Locations (60)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
UC San Diego Health - Sulpizio Cardiovascular CenterLa JollaCalifornia92037-
Cedars-Sinai Medical Center (Smidt Heart Institute)Los AngelesCalifornia90048-
Keck Medical Center of USC (Outpatient Clinic)Los AngelesCalifornia90033-
UCLA Medical Center Cardiovascular ClinicLos AngelesCalifornia90095-
University of California San FranciscoSan FranciscoCalifornia94143-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Yale New Haven HospitalNew HavenConnecticut06519-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Holy Cross Medical Group - Cardiology AssociatesFort LauderdaleFlorida33308-
Investigational Drug Services, AdventHealth OrlandoOrlandoFlorida32804-
Emory ClinicAtlantaGeorgia30322-
Piedmont Heart Institute (CPET)FayettevilleGeorgia30214-
The Queen's Medical Center-PunchbowlHonoluluHawaii96813-
Northwestern UniversityEvanstonIllinois60208-
Ascension St. VincentIndianapolisIndiana46260-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
The University of Kansas Medical CenterKansas CityKansas66160-
MedStar Union Memorial HospitalBaltimoreMaryland21218-
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01803-
Michigan MedicineAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
M Health Fairview University of Minnesota Medical Center - East BankMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Morristown Medical CenterMorristownNew Jersey07960-
Northwell Health North Shore University HospitalManhassetNew York11030-
Columbia University Medical Center/New York Presbyterian HospitalNew YorkNew York10032-
Mount Sinai HospitalNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
Weill Cornell MedicineNew YorkNew York10021-
Westchester Medical CenterValhallaNew York10595-
Sanger Heart & Vascular Institute - HCM ClinicCharlotteNorth Carolina28204-
The Lindner Research Center at The Christ HospitalCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Oregon Health & Science UniversityPortlandOregon97239-
Providence St. Vincent Medical CenterPortlandOregon97225-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC PresbyterianPittsburghPennsylvania15213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Greenville Memorial HospitalGreenvilleSouth Carolina29605-5601-
Ascension Saint Thomas Heart WestNashvilleTennessee37205-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Baylor College of MedicineHoustonTexas77030-
Houston Methodist HospitalHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
University of Utah HealthSalt Lake CityUtah84132-
University of VirginiaCharlottesvilleVirginia22903-
Inova Health Care ServicesFalls ChurchVirginia22042-
VCU Health Downtown Medical CampusRichmondVirginia23298-
Carilion Clinic CardiologyRoanokeVirginia24014-
Virginia Mason Medical CenterSeattleWashington98101-
Providence Sacred Heart Medical Center & Children's Hospital (CPET)SpokaneWashington99204-
WVU MedicineMorgantownWest Virginia26506-
University of Wisconsin Hospitals and ClinicsMadisonWisconsin53792-
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226-

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Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUC San Diego Health - Sulpizio Cardiovascular Center· La Jolla, CACedars-Sinai Medical Center (Smidt Heart Institute)· Los Angeles, CAKeck Medical Center of USC (Outpatient Clinic)· Los Angeles, CAUCLA Medical Center Cardiovascular Clinic· Los Angeles, CAUniversity of California San Francisco· San Francisco, CA