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: Recruiting
Location: See all (135) 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
Alaska
Alaska Heart and Vascular Institute
RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
UC San Diego Health - Sulpizio Cardiovascular Center
RECRUITING
La Jolla
Cedars-Sinai Medical Center (Smidt Heart Institute)
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Holy Cross Medical Group - Cardiology Associates
RECRUITING
Fort Lauderdale
Investigational Drug Services, AdventHealth Orlando
RECRUITING
Orlando
Georgia
Emory Clinic
RECRUITING
Atlanta
Piedmont Heart Institute (CPET)
RECRUITING
Fayetteville
Hawaii
The Queen's Medical Center-Punchbowl
RECRUITING
Honolulu
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Evanston
Indiana
Ascension St. Vincent
RECRUITING
Indianapolis
Kansas
The University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Lahey Hospital & Medical Center
RECRUITING
Burlington
Maryland
MedStar Union Memorial Hospital
RECRUITING
Baltimore
Michigan
Michigan Medicine
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
North Carolina
Sanger Heart & Vascular Institute - HCM Clinic
RECRUITING
Charlotte
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Nevada
Arizona Cardiovascular Research Center
RECRUITING
Las Vegas
New York
Columbia University Medical Center/New York Presbyterian Hospital
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Westchester Medical Center
RECRUITING
Valhalla
Ohio
The Lindner Research Center at The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Oregon Health & Science University
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
UPMC Presbyterian
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Greenville Memorial Hospital
RECRUITING
Greenville
Tennessee
Ascension Saint Thomas Heart West
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Houston Methodist Hospital
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah Health
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Inova Health Care Services
RECRUITING
Falls Church
Carilion Clinic Cardiology
RECRUITING
Roanoke
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Providence Sacred Heart Medical Center & Children's Hospital (CPET)
RECRUITING
Spokane
Wisconsin
University of Wisconsin Hospitals and Clinics
RECRUITING
Madison
Medical College of Wisconsin/Froedtert Hospital
RECRUITING
Milwaukee
West Virginia
WVU Medicine
RECRUITING
Morgantown
Other Locations
Argentina
Hospital Italiano de Buenos Aires Juan Domingo Peron
RECRUITING
Buenos Aires
Australia
Flinders Medical Centre Cardiology Research
RECRUITING
Adelaide
The Prince Charles Hospital
RECRUITING
Chermside
Fiona Stanley Hospital, AHF Unit
RECRUITING
Murdoch
Brazil
Fundacao Felice Rocho / Hospital Felicio Rocho
RECRUITING
Minas Gerais
NUPEC Cardio / Cardio HVC
RECRUITING
Minas Gerais
Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA
RECRUITING
Ondina
Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)
RECRUITING
São Paulo
Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP
RECRUITING
São Paulo
Instituto Dante Pazzanese de Cardiologia
RECRUITING
São Paulo
Instituto do Coracao do Hospital de Aguiar
RECRUITING
São Paulo
Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas
RECRUITING
São Paulo
Canada
QEII Health Science Centre (Halifax Infirmary site)
RECRUITING
Halifax
China
Fuwai Hospital, CAMS & PUMC
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The First Hospital of Jilin University
RECRUITING
Jilin
Zhongda Hospital Southeast University
RECRUITING
Nanjin
Shanghai Ruijin Hospital Luwan Branch
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
People's Hospital of Liaoning Province
RECRUITING
Shenyang
Remin Hospital of Wuhan University
RECRUITING
Wuhan
The 1st affi. Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The 1st affiliated Hospital of Zhengzhou University
RECRUITING
Zhenzhou
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Department of Cardiology Copenhagen University Hospital, Bispebjerg
RECRUITING
Copenhagen
Odense University Hospital, Department of Cardiology
RECRUITING
Odense
France
Assistance Publique Hopitaux de Marseille
RECRUITING
Marseille
Centre Hospitalier Universitaire De Montpellier
RECRUITING
Montpellier
Clinique Du Millenaire
RECRUITING
Montpellier
Assistance Publique Hopitaux de Paris
RECRUITING
Paris
Assistance Publique Hopitaux De Paris
RECRUITING
Paris
Centre Hospitalier Universitaire De Bordeaux
RECRUITING
Pessac
Centre Hospitalier Universitaire De Nantes
RECRUITING
Saint-herblain
Hopital Rangueil
RECRUITING
Toulouse
Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
RECRUITING
Berlin
Herzzentrum der Universitatsmedizin Gottingen
RECRUITING
Göttingen
Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie
RECRUITING
Heidelberg
Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)
RECRUITING
Jena
Hungary
Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
RECRUITING
Budapest
University of Szeged
RECRUITING
Szeged
Israel
The Barzilai University Medical Center 2 - Cardiology Division
RECRUITING
Ashkelon
Division of Cardiology Hadassah Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Ziv Medical Center
RECRUITING
Safed
Italy
UOC Cardiologica
RECRUITING
Brescia
Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia
RECRUITING
Florence
Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti
RECRUITING
Foggia
Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II
RECRUITING
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
RECRUITING
Pisa
Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
RECRUITING
Roma
Cardiology Department IRCCS San Donato Hospital - University of Milan
RECRUITING
San Donato Milanese
Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia
RECRUITING
Trieste
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Erasmus University Medical Center
RECRUITING
Rotterdam
Poland
Kardio Brynow Sp. z o.o.
RECRUITING
Katowice
Portugal
Unidade Local de Saude da Regiao de Aveiro, E.P.E.
RECRUITING
Aveiro
Hospital CUF Descobertas, Lisbon, Cadiology Department
RECRUITING
Lisbon
Hospital da Luz
RECRUITING
Lisbon
Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia
RECRUITING
Lisbon
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos
RECRUITING
Málaga
Hospital Clinico Universitario Virgen de la
RECRUITING
Murcia
Hospital Son Llatzer
RECRUITING
Palma De Mallorca
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
United Kingdom
NHS Tayside Ninewells Hospital & Medical School
RECRUITING
Dundee
NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
RECRUITING
Glasgow
Barts Health NHS Trust St Bartholomew's Hospital
RECRUITING
London
Royal Brompton Hospital
RECRUITING
London
St George's University Hospitals NHS Foundation Trust,
RECRUITING
London
Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)
RECRUITING
Oxford
Contact Information
Primary
Cytokinetics MD
medicalaffairs@cytokinetics.com
650-624-2929
Time Frame
Start Date: 2023-08-30
Estimated 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