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

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
Interventions
DRUG

Aficamten

Oral Tablet

DRUG

Placebo

Oral Tablet

Trial Locations (135)

119

RECRUITING

Hospital Italiano de Buenos Aires Juan Domingo Peron, Buenos Aires

1105

RECRUITING

Amsterdam UMC, location AMC, Amsterdam

1122

RECRUITING

Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika, Budapest

2400

RECRUITING

Department of Cardiology Copenhagen University Hospital, Bispebjerg, Copenhagen

3015

RECRUITING

Erasmus University Medical Center, Rotterdam

4032

RECRUITING

The Prince Charles Hospital, Chermside

5000

RECRUITING

Odense University Hospital, Department of Cardiology, Odense

5042

RECRUITING

Flinders Medical Centre Cardiology Research, Adelaide

6150

RECRUITING

Fiona Stanley Hospital, AHF Unit, Murdoch

6725

RECRUITING

University of Szeged, Szeged

8200

RECRUITING

Aarhus University Hospital, Aarhus

10016

RECRUITING

NYU Langone Health, New York

10021

RECRUITING

Weill Cornell Medicine, New York

10029

RECRUITING

Mount Sinai Hospital, New York

10032

RECRUITING

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

10595

RECRUITING

Westchester Medical Center, Valhalla

13005

RECRUITING

Assistance Publique Hopitaux de Marseille, Marseille

13353

RECRUITING

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

15006

RECRUITING

Complejo Hospitalario Universitario A Coruna, A Coruña

15213

RECRUITING

UPMC Presbyterian, Pittsburgh

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

20010

RECRUITING

MedStar Washington Hospital Center, Washington D.C.

20097

RECRUITING

Cardiology Department IRCCS San Donato Hospital - University of Milan, San Donato Milanese

21218

RECRUITING

MedStar Union Memorial Hospital, Baltimore

22042

RECRUITING

Inova Health Care Services, Falls Church

22903

RECRUITING

University of Virginia, Charlottesville

24014

RECRUITING

Carilion Clinic Cardiology, Roanoke

25123

RECRUITING

UOC Cardiologica, Brescia

26506

RECRUITING

WVU Medicine, Morgantown

28040

RECRUITING

Hospital Clinico San Carlos, Madrid

28204

RECRUITING

Sanger Heart & Vascular Institute - HCM Clinic, Charlotte

28220

RECRUITING

Hospital Universitario Puerta de Hierro, Madrid

29010

RECRUITING

Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos, Málaga

29425

RECRUITING

Medical University of South Carolina, Charleston

30120

RECRUITING

Hospital Clinico Universitario Virgen de la, Murcia

30214

RECRUITING

Piedmont Heart Institute (CPET), Fayetteville

30322

RECRUITING

Emory Clinic, Atlanta

31059

RECRUITING

Hopital Rangueil, Toulouse

32804

RECRUITING

Investigational Drug Services, AdventHealth Orlando, Orlando

33308

RECRUITING

Holy Cross Medical Group - Cardiology Associates, Fort Lauderdale

33600

RECRUITING

Centre Hospitalier Universitaire De Bordeaux, Pessac

34000

RECRUITING

Clinique Du Millenaire, Montpellier

34148

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia, Trieste

34295

RECRUITING

Centre Hospitalier Universitaire De Montpellier, Montpellier

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

36312

RECRUITING

Hospital Alvaro Cunqueiro, Vigo

37007

RECRUITING

Hospital Universitario de Salamanca, Salamanca

37075

RECRUITING

Herzzentrum der Universitatsmedizin Gottingen, Göttingen

37205

RECRUITING

Ascension Saint Thomas Heart West, Nashville

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

44195

RECRUITING

Cleveland Clinic, Cleveland

44800

RECRUITING

Centre Hospitalier Universitaire De Nantes, Saint-Herblain

45219

RECRUITING

The Lindner Research Center at The Christ Hospital, Cincinnati

46260

RECRUITING

Ascension St. Vincent, Indianapolis

48109

RECRUITING

Michigan Medicine, Ann Arbor

48202

RECRUITING

Henry Ford Hospital, Detroit

50134

RECRUITING

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

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

53226

RECRUITING

Medical College of Wisconsin/Froedtert Hospital, Milwaukee

53792

RECRUITING

University of Wisconsin Hospitals and Clinics, Madison

55455

RECRUITING

M Health Fairview University of Minnesota Medical Center - East Bank, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

56124

RECRUITING

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

60208

RECRUITING

Northwestern University, Evanston

64111

RECRUITING

Saint Luke's Hospital of Kansas City, Kansas City

66160

RECRUITING

The University of Kansas Medical Center, Kansas City

69120

RECRUITING

Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie, Heidelberg

71122

RECRUITING

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

75010

RECRUITING

Assistance Publique Hopitaux De Paris, Paris

75015

RECRUITING

Assistance Publique Hopitaux de Paris, Paris

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

Houston Methodist Hospital, Houston

80131

RECRUITING

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

84107

RECRUITING

Intermountain Medical Center, Murray

84132

RECRUITING

University of Utah Health, Salt Lake City

89118

RECRUITING

Arizona Cardiovascular Research Center, Las Vegas

90048

RECRUITING

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

90502

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92037

RECRUITING

UC San Diego Health - Sulpizio Cardiovascular Center, La Jolla

94143

RECRUITING

University of California San Francisco, San Francisco

96813

RECRUITING

The Queen's Medical Center-Punchbowl, Honolulu

97225

RECRUITING

Providence St. Vincent Medical Center, Portland

97239

RECRUITING

Oregon Health & Science University, Portland

98101

RECRUITING

Virginia Mason Medical Center, Seattle

99204

RECRUITING

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

99508

RECRUITING

Alaska Heart and Vascular Institute, Anchorage

100034

RECRUITING

Peking University First Hospital, Beijing

100037

RECRUITING

Fuwai Hospital, CAMS & PUMC, Beijing

110067

RECRUITING

People's Hospital of Liaoning Province, Shenyang

130031

RECRUITING

The First Hospital of Jilin University, Jilin

200020

RECRUITING

Shanghai Ruijin Hospital Luwan Branch, Shanghai

200032

RECRUITING

Zhongshan Hospital Fudan University, Shanghai

210009

RECRUITING

Zhongda Hospital Southeast University, Nanjin

430060

RECRUITING

Remin Hospital of Wuhan University, Wuhan

450052

RECRUITING

The 1st affiliated Hospital of Zhengzhou University, Zhenzhou

519041

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

710061

RECRUITING

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

1311001

RECRUITING

Ziv Medical Center, Safed

4428164

RECRUITING

Meir Medical Center, Kfar Saba

5265601

RECRUITING

The Chaim Sheba Medical Center, Ramat Gan

7830604

RECRUITING

The Barzilai University Medical Center 2 - Cardiology Division, Ashkelon

9112001

RECRUITING

Division of Cardiology Hadassah Medical Center, Jerusalem

06519

RECRUITING

Yale New Haven Hospital, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital, Boston

01803

RECRUITING

Lahey Hospital & Medical Center, Burlington

07960

RECRUITING

Morristown Medical Center, Morristown

29605-5601

RECRUITING

Greenville Memorial Hospital, Greenville

40170-0130

RECRUITING

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

30110-934

RECRUITING

Fundacao Felice Rocho / Hospital Felicio Rocho, Minas Gerais

30220-140

RECRUITING

NUPEC Cardio / Cardio HVC, Minas Gerais

04012-909

RECRUITING

Instituto Dante Pazzanese de Cardiologia, São Paulo

05403-900

RECRUITING

Instituto do Coracao do Hospital de Aguiar, São Paulo

12916-542

RECRUITING

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

13060-080

RECRUITING

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

14051-140

RECRUITING

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

B3H 3A7

RECRUITING

QEII Health Science Centre (Halifax Infirmary site), Halifax

07747

RECRUITING

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

00163

RECRUITING

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

40-555

RECRUITING

Kardio Brynow Sp. z o.o., Katowice

3814-501

RECRUITING

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

1150-199

RECRUITING

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

1500-650

RECRUITING

Hospital da Luz, Lisbon

1998-018

RECRUITING

Hospital CUF Descobertas, Lisbon, Cadiology Department, Lisbon

08025

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08036

RECRUITING

Hospital Clinic i Provincial de Barcelona, Barcelona

07198

RECRUITING

Hospital Son Llatzer, Palma de Mallorca

DD1 9SY

RECRUITING

NHS Tayside Ninewells Hospital & Medical School, Dundee

G51 4TF

RECRUITING

NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital, Glasgow

EC1A 7BE

RECRUITING

Barts Health NHS Trust St Bartholomew's Hospital, London

SW17 0QT

RECRUITING

St George's University Hospitals NHS Foundation Trust,, London

SW3 6NP

RECRUITING

Royal Brompton Hospital, London

OX3 9DU

RECRUITING

Oxford Centre for Clinical Magnetic Resonance Research (Ocmr), Oxford

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Bayer

INDUSTRY

lead

Cytokinetics

INDUSTRY

NCT06081894 - Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM | Biotech Hunter | Biotech Hunter