Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Interventions
DRUG

Aficamten (5 - 20 mg)

Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.

Trial Locations (90)

1122

Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika, Budapest

2100

The Heart Center, Department of Cardiology, Copenhagen

2400

Copenhagen University Hospital, Copenhagen

3015

Erasmus Medical Center Department of Cardiology, Rotterdam

8200

Department of Cardiology Aarhus University Hospital, Aarhus

9000

Department of Cardiology Aalborg University Hospital, Aalborg

10016

NYU Langone Health, New York

10029

Mount Sinai Hospital, New York

10032

Columbia University Medical Center/New York Presbyterian Hospital, New York

10595

Westchester Medical Center, Valhalla

13353

Charite-Universitaetsmedizin Berlin, Berlin

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

15213

UPMC Presbyterian, Pittsburgh

19104

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine), Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

22042

Inova Health Care Services, Falls Church

22908

University of Virginia Health System University Hospital, Charlottesville

27710

Duke Cardiology at Southpoint, Durham

28204

Sanger Heart & Vascular Institute - HCM Clinic, Charlotte

28220

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

29425

Medical University of South Carolina, Charleston

30120

Hospital Clinico Universitario Virgen de la Arrixaca, Madrid

30214

Piedmont Fayette Hospital, Fayetteville

30322

Emory Clinic, Atlanta

33308

Holy Cross Hospital / Cardiology Associates, Fort Lauderdale

33604

Hopital cardiologique de Haut-Leveque, Pessac

35033

Centre hospitalier universitaire (CHU) de Rennes-Hopital Pontchaillou, Rennes

37007

Hospital Universitario de Salamanca, Salamanca

37075

Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie, Goettigen

37205

Ascension Saint Thomas Heart West, Nashville

37232

Vanderbilt University Medical Center, Nashville

41009

Hospital Universitario Virgen Macarena-merge, Seville

41013

Hospital Universitario Virgen del Rocío, Seville

44093

CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires, Nantes

44195

Cleveland Clinic, Cleveland

45147

Universitaetsklinikum Essen, Essen

48109

Michigan Medicine - University of Michigan, Ann Arbor

University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center), Ann Arbor

48202

Henry Ford Hospital, Detroit

50134

Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare, Florence

56124

Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo, Pisa

60208

Northwestern University, Evanston

64111

Saint Luke's Hospital of Kansas City, Kansas City

69120

Universitaesklinkum Heidelberg, Heidelberg

75010

Hopital Lariboisiere, Paris

75015

Hopital Europeen Georges Pompidou, Paris

75390

The University of Texas Southwestern Medical Center at Dallas, Dallas

76104

Ascension St. John Clinical Research Institute, Tulsa

77030

CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston

Houston Methodist Hospital, Houston

84107

Intermountain Medical Center, Murray

84132

University of Utah Health, Salt Lake City

85054

Mayo Clinic Building - Phoenix, Phoenix

90048

Cedar-Sinai Medical Center, Los Angeles

Cedars-Sinai Medical Center (Smidt Heart Institute), Los Angeles

92037

UC San Diego Health - Sulpizio Cardiovascular Center, La Jolla

94143

UCSF Medical Center, San Francisco

97078

Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC), Würzburg

97225

Providence St. Vincent Medical Center, Portland

97239

Oregon Health & Science University, Portland

99508

Alaska Heart and Vascular Institute, Anchorage

130005

Hopital de la Timone Service de cardiologie, Marseille

1311001

Ziv Medical Center, Safed

5265601

The Chaim Sheba Medical Center, Ramat Gan

7830604

The Barzilai University Medical Center, Ashkelon

9112001

Hadassah Medical Center- Ein Kerem, Jerusalem

06519

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

01805

Lahey Hospital & Medical Center, Burlington

07960

Morristown Medical Center, Morristown

04012-909

Instituto Dante Pazzanese de Cardiologia, São Paulo

G1V 4G5

Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval, Québec

128 08

Il. Interni klinika kardiologie a angiologie, Prague

07747

Universitaetsklinikum Jena, Jena

00189

Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea, Roma

6229 HX

Maastricht University Medical Center (MUMC), Maastricht

40-555

Kardio Brynow S.C., Katowice

04-628

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca, Warsaw

3814-501

Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department, Aveiro

Unknown

Hospital da Luz, Lisbon

08036

Hospital Clinic Barcelona, Barcelona

07198

Hospital Universitario Son Llatzer, Palma

B15 2GW

Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust, Birmingham

G51 4TF

Glasgow Clinical Research Facility Neuroscience Institute, Glasgow

L14 3PE

Liverpool Heart and Chest Hospital, Liverpool

EC1A 7BE

St Bartholomew's Hospital, London

SW17 0QT

St George's University Hospitals NHS Foundation Trust, London

SW3 6NP

Royal Brompton Hospital, London

OX3 9DU

Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cytokinetics

INDUSTRY

NCT04848506 - Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM | Biotech Hunter | Biotech Hunter