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

Status: Active_not_recruiting
Location: See all (180) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Between 18-85 years of age

• Body mass index \< 40 kg/m2

• Diagnosed with nHCM and has a screening echocardiogram with the following:

‣ End-diastolic left ventricular (LV) wall thickness:

• ≥ 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 AND

∙ Resting LVOT-G \< 30 mmHg AND Valsalva LVOT-G \< 50 mmHg AND

∙ LVEF ≥ 60%

⁃ Participants with a history of intracavitary obstruction are eligible.

• NYHA class II or III

• Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex

• KCCQ-CSS score of ≤ 85

• NT-proBNP of:

‣ NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR

⁃ For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles
Keck Medical Center of USC (Outpatient Clinic)
Los Angeles
UCLA Medical Center Cardiovascular Clinic
Los Angeles
University of California San Francisco
San Francisco
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Florida
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale
Investigational Drug Services, AdventHealth Orlando
Orlando
Georgia
Emory Clinic
Atlanta
Piedmont Heart Institute (CPET)
Fayetteville
Hawaii
The Queen's Medical Center-Punchbowl
Honolulu
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Northwestern University
Evanston
Indiana
Ascension St. Vincent
Indianapolis
Kansas
The University of Kansas Medical Center
Kansas City
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Lahey Hospital & Medical Center
Burlington
Maryland
MedStar Union Memorial Hospital
Baltimore
Michigan
Michigan Medicine
Ann Arbor
Henry Ford Hospital
Detroit
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis
Mayo Clinic
Rochester
Missouri
Saint Luke's Hospital of Kansas City
Kansas City
North Carolina
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte
New Jersey
Morristown Medical Center
Morristown
New York
Northwell Health North Shore University Hospital
Manhasset
Columbia University Medical Center/New York Presbyterian Hospital
New York
Mount Sinai Hospital
New York
NYU Langone Health
New York
Weill Cornell Medicine
New York
Westchester Medical Center
Valhalla
Ohio
The Lindner Research Center at The Christ Hospital
Cincinnati
Cleveland Clinic
Cleveland
University Hospitals Cleveland Medical Center
Cleveland
Oregon
Oregon Health & Science University
Portland
Providence St. Vincent Medical Center
Portland
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
UPMC Presbyterian
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Greenville Memorial Hospital
Greenville
Tennessee
Ascension Saint Thomas Heart West
Nashville
Vanderbilt University Medical Center
Nashville
Texas
Baylor College of Medicine
Houston
Houston Methodist Hospital
Houston
Utah
Intermountain Medical Center
Murray
University of Utah Health
Salt Lake City
Virginia
University of Virginia
Charlottesville
Inova Health Care Services
Falls Church
VCU Health Downtown Medical Campus
Richmond
Carilion Clinic Cardiology
Roanoke
Washington
Virginia Mason Medical Center
Seattle
Providence Sacred Heart Medical Center & Children's Hospital (CPET)
Spokane
Wisconsin
University of Wisconsin Hospitals and Clinics
Madison
Aurora St. Luke's Medical Center
Milwaukee
Medical College of Wisconsin/Froedtert Hospital
Milwaukee
West Virginia
WVU Medicine
Morgantown
Other Locations
Argentina
Hospital Italiano de Buenos Aires Juan Domingo Peron
Buenos Aires
ICBA - Instituto Cardiovascular de Buenos Aires
Buenos Aires
Hospital Privado Centro Medico de Cordoba S.A
Córdoba
Australia
Flinders Medical Centre Cardiology Research
Adelaide
The Prince Charles Hospital
Chermside
Fiona Stanley Hospital, AHF Unit
Murdoch
Brazil
Fundacao Felice Rocho / Hospital Felicio Rocho
Minas Gerais
NUPEC Cardio / Cardio HVC
Minas Gerais
Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA
Ondina
CLINICOR Clinica Cardiologica LTDA
Ribeirão Preto
Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)
São Paulo
Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo
Instituto do Coracao do Hospital de Aguiar
São Paulo
Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas
São Paulo
Canada
Royal Alexandra Hospital
Edmonton
Health Sciences North
Greater Sudbury
QEII Health Science Centre (Halifax Infirmary site)
Halifax
Montreal Heart Institute
Montreal
St. Boniface Hospital
Winnipeg
China
Fuwai Hospital, CAMS & PUMC
Beijing
Peking University First Hospital
Beijing
Guangdong Provincial People's Hospital
Guangzhou
The 1st Affiliated Hospital of Sun Yat-sen University
Guangzhou
The First Hospital of Jilin University
Jilin
Zhongda Hospital Southeast University
Nanjin
Shanghai Ruijin Hospital Luwan Branch
Shanghai
Zhongshan Hospital Fudan University
Shanghai
People's Hospital of Liaoning Province
Shenyang
Remin Hospital of Wuhan University
Wuhan
The 1st affi. Hospital of Xi'an Jiaotong University
Xi'an
The 1st affiliated Hospital of Zhengzhou University
Zhenzhou
Denmark
Aarhus University Hospital
Aarhus
Department of Cardiology Copenhagen University Hospital, Bispebjerg
Copenhagen
Odense University Hospital, Department of Cardiology
Odense
France
Assistance Publique Hopitaux de Marseille
Marseille
Centre Hospitalier Universitaire De Montpellier
Montpellier
Clinique Du Millenaire
Montpellier
Assistance Publique Hopitaux de Paris
Paris
Assistance Publique Hopitaux De Paris
Paris
Centre Hospitalier Universitaire De Bordeaux
Pessac
Centre Hospitalier Universitaire De Nantes
Saint-herblain
Hopital Rangueil
Toulouse
Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin
Herzzentrum der Universitatsmedizin Gottingen
Göttingen
Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie
Heidelberg
Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)
Jena
Greece
Evangelismos General Hospital of Athens
Athens
Hippokration General Hospital of Athens
Athens
University General Hospital Attikon
Attiki
Onassis Cardiac Surgery Center
Kallithea
Hungary
Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest
University of Szeged
Szeged
Iceland
Landspitali University Hospital
Reykjavik
Israel
The Barzilai University Medical Center 2 - Cardiology Division
Ashkelon
Division of Cardiology Hadassah Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
The Chaim Sheba Medical Center
Ramat Gan
Ziv Medical Center
Safed
Italy
UOC Cardiologica
Brescia
Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia
Florence
Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti
Foggia
Dipartimento Cardio-toraco- vascolare, ASST Grande Ospedale Metropolitano, NiguardaPiazza Ospedale Maggiore, 3
Milan
Unita Operativa di Riabilitazione Cardiologica, Istituto Auxologico Italiano, IRCCS - Auxologico San Luca, Piazzale Brescia, 20
Milan
Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II
Napoli
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
Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
Roma
Cardiology Department IRCCS San Donato Hospital - University of Milan
San Donato Milanese
Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia
Trieste
Japan
Kyushu University Hospital
Fukuoka
Hyogo Prefectural Harima-Himeii General Medical Center
Hyōgo
Kobe City Medical Center General Hospital
Hyōgo
University of Tsukuba Hospital
Ibaraki
SHOWA Medical University Fujigaoka Hospital
Kanagawa
Kochi Medical School Hospital
Kochi
National Hospital Organization Kyoto Medical Center
Kyoto
Mie University Hospital
Mie
National University Corporation Tohoku University Tohoku University Hospital
Miyagi
Shinshu University Hospital
Nagano
National Cerebral and Cardiovascular Center
Osaka
Osaka General Medical Center
Osaka
Osaka Medical and Pharmaceutical University Hospital
Osaka
Osaka Metropolitan University Hospital
Osaka
Kitasato University Hospital
Sagamihara
Saitama Medical University International Medical Center
Saitama
Hamamatsu University Hospital
Shizuoka
Nippon Medical School Hospital
Tokyo
St. Luke's International Hospital
Tokyo
Teikyo University Hospital
Tokyo
The University of Tokyo Hospital
Tokyo
Tokyo Women's Medical University Hospital
Tokyo
Netherlands
Amsterdam UMC, location AMC
Amsterdam
P. Debyelaan 25
Maastricht
Erasmus University Medical Center
Rotterdam
Poland
Kardio Brynow Sp. z o.o.
Katowice
Portugal
Unidade Local de Saude da Regiao de Aveiro, E.P.E.
Aveiro
Unidade Local de Saude do Alto Ave, E.P.E
Creixomil
Hospital CUF Descobertas, Lisbon, Cadiology Department
Lisbon
Hospital da Luz
Lisbon
Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia
Lisbon
Spain
Complejo Hospitalario Universitario A Coruna
A Coruña
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital General Universitario Gregorio Marañón (HGUGM), Calle del Doctor Esquerdo, 46.
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos
Málaga
Hospital Clinico Universitario Virgen de la
Murcia
Hospital Son Llatzer
Palma De Mallorca
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Alvaro Cunqueiro
Vigo
United Kingdom
NHS Tayside Ninewells Hospital & Medical School
Dundee
NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
Glasgow
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Barts Health NHS Trust St Bartholomew's Hospital
London
Royal Brompton Hospital
London
St George's University Hospitals NHS Foundation Trust,
London
Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)
Oxford
Time Frame
Start Date: 2023-08-30
Completion Date: 2026-09
Participants
Target number of participants: 500
Treatments
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.
Sponsors
Collaborators: Bayer, Sanofi
Leads: Cytokinetics

This content was sourced from clinicaltrials.gov