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ACTIVE NOT RECRUITING
NCT06081894
PHASE3

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

Sponsor: Cytokinetics

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-08-30

Completion Date

2026-09

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Aficamten

Oral Tablet

DRUG

Placebo

Oral Tablet

Locations (180)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UC San Diego Health - Sulpizio Cardiovascular Center

La Jolla, California, United States

Keck Medical Center of USC (Outpatient Clinic)

Los Angeles, California, United States

Cedars-Sinai Medical Center (Smidt Heart Institute)

Los Angeles, California, United States

UCLA Medical Center Cardiovascular Clinic

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Holy Cross Medical Group - Cardiology Associates

Fort Lauderdale, Florida, United States

Investigational Drug Services, AdventHealth Orlando

Orlando, Florida, United States

Emory Clinic

Atlanta, Georgia, United States

Piedmont Heart Institute (CPET)

Fayetteville, Georgia, United States

The Queen's Medical Center-Punchbowl

Honolulu, Hawaii, United States

Northwestern University

Evanston, Illinois, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Michigan Medicine

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Morristown Medical Center

Morristown, New Jersey, United States

Northwell Health North Shore University Hospital

Manhasset, New York, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

Westchester Medical Center

Valhalla, New York, United States

Sanger Heart & Vascular Institute - HCM Clinic

Charlotte, North Carolina, United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Ascension Saint Thomas Heart West

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Health Care Services

Falls Church, Virginia, United States

VCU Health Downtown Medical Campus

Richmond, Virginia, United States

Carilion Clinic Cardiology

Roanoke, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Providence Sacred Heart Medical Center & Children's Hospital (CPET)

Spokane, Washington, United States

WVU Medicine

Morgantown, West Virginia, United States

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

Hospital Italiano de Buenos Aires Juan Domingo Peron

Buenos Aires, Argentina

ICBA - Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, Argentina

The Prince Charles Hospital

Chermside, Queensland, Australia

Flinders Medical Centre Cardiology Research

Adelaide, South Australia, Australia

Fiona Stanley Hospital, AHF Unit

Murdoch, Australia

Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA

Ondina, Salvador, Brazil

Fundacao Felice Rocho / Hospital Felicio Rocho

Minas Gerais, Brazil

NUPEC Cardio / Cardio HVC

Minas Gerais, Brazil

CLINICOR Clinica Cardiologica LTDA

Ribeirão Preto, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto do Coracao do Hospital de Aguiar

São Paulo, Brazil

Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)

São Paulo, Brazil

Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas

São Paulo, Brazil

Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP

São Paulo, Brazil

Royal Alexandra Hospital

Edmonton, Alberta, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

QEII Health Science Centre (Halifax Infirmary site)

Halifax, Canada

The 1st Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Peking University First Hospital

Beijing, China

Fuwai Hospital, CAMS & PUMC

Beijing, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Hospital of Jilin University

Jilin, China

Zhongda Hospital Southeast University

Nanjin, China

Shanghai Ruijin Hospital Luwan Branch

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, China

People's Hospital of Liaoning Province

Shenyang, China

Remin Hospital of Wuhan University

Wuhan, China

The 1st affi. Hospital of Xi'an Jiaotong University

Xi'an, China

The 1st affiliated Hospital of Zhengzhou University

Zhenzhou, China

Aarhus University Hospital

Aarhus, Denmark

Department of Cardiology Copenhagen University Hospital, Bispebjerg

Copenhagen, Denmark

Odense University Hospital, Department of Cardiology

Odense, Denmark

Assistance Publique Hopitaux de Marseille

Marseille, France

Clinique Du Millenaire

Montpellier, France

Centre Hospitalier Universitaire De Montpellier

Montpellier, France

Assistance Publique Hopitaux De Paris

Paris, France

Assistance Publique Hopitaux de Paris

Paris, France

Centre Hospitalier Universitaire De Bordeaux

Pessac, France

Centre Hospitalier Universitaire De Nantes

Saint-Herblain, France

Hopital Rangueil

Toulouse, France

Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie

Berlin, Germany

Herzzentrum der Universitatsmedizin Gottingen

Göttingen, Germany

Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie

Heidelberg, Germany

Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)

Jena, Germany

Evangelismos General Hospital of Athens

Athens, Greece

"Hippokration" General Hospital of Athens

Athens, Greece

University General Hospital Attikon

Attiki, Greece

Onassis Cardiac Surgery Center

Kallithea, Greece

Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika

Budapest, Hungary

University of Szeged

Szeged, Hungary

Landspitali University Hospital

Reykjavik, Iceland

The Barzilai University Medical Center 2 - Cardiology Division

Ashkelon, Israel

Division of Cardiology Hadassah Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Ziv Medical Center

Safed, Israel

Cardiology Department IRCCS San Donato Hospital - University of Milan

San Donato Milanese, Milano, Italy

UOC Cardiologica

Brescia, Italy

Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia

Florence, Italy

Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti

Foggia, Italy

Unita Operativa di Riabilitazione Cardiologica, Istituto Auxologico Italiano, IRCCS - Auxologico San Luca, Piazzale Brescia, 20

Milan, Italy

Dipartimento Cardio-toraco- vascolare, ASST Grande Ospedale Metropolitano, NiguardaPiazza Ospedale Maggiore, 3

Milan, Italy

Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II

Naples, Italy

Fondazione Toscana Gabriele Monasterio Per La ricerca Medica e Di Sanita Pubbliga (FTGM) Cardio-Toracic-UOC Cardiology and Cardiovasulcar Medicine San Cataldo Hospital at CNR

Pisa, Italy

Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele

Roma, Italy

Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia

Trieste, Italy

Kyushu University Hospital

Fukuoka, Japan

Kobe City Medical Center General Hospital

Hyōgo, Japan

Hyogo Prefectural Harima-Himeii General Medical Center

Hyōgo, Japan

University of Tsukuba Hospital

Ibaraki, Japan

SHOWA Medical University Fujigaoka Hospital

Kanagawa, Japan

Kochi Medical School Hospital

Kochi, Japan

National Hospital Organization Kyoto Medical Center

Kyoto, Japan

Mie University Hospital

Mie, Japan

National University Corporation Tohoku University Tohoku University Hospital

Miyagi, Japan

Shinshu University Hospital

Nagano, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Osaka General Medical Center

Osaka, Japan

National Cerebral and Cardiovascular Center

Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan

Kitasato University Hospital

Sagamihara, Japan

Saitama Medical University International Medical Center

Saitama, Japan

Hamamatsu University Hospital

Shizuoka, Japan

St. Luke's International Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

The University of Tokyo Hospital

Tokyo, Japan

Tokyo Women's Medical University Hospital

Tokyo, Japan

Teikyo University Hospital

Tokyo, Japan

P. Debyelaan 25

Maastricht, HX, Netherlands

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Kardio Brynow Sp. z o.o.

Katowice, Poland

Unidade Local de Saude do Alto Ave, E.P.E

Creixomil, Guimaraes, Portugal

Unidade Local de Saude da Regiao de Aveiro, E.P.E.

Aveiro, Portugal

Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia

Lisbon, Portugal

Hospital da Luz

Lisbon, Portugal

Hospital CUF Descobertas, Lisbon, Cadiology Department

Lisbon, Portugal

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañón (HGUGM), Calle del Doctor Esquerdo, 46.

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos

Málaga, Spain

Hospital Clinico Universitario Virgen de la

Murcia, Spain

Hospital Son Llatzer

Palma de Mallorca, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

NHS Tayside Ninewells Hospital & Medical School

Dundee, Scotland, United Kingdom

NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital

Glasgow, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust St Bartholomew's Hospital

London, United Kingdom

St George's University Hospitals NHS Foundation Trust,

London, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)

Oxford, United Kingdom