Hypertrophic Cardiomyopathy Clinical Trial

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

Summary

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants who meet all the following criteria at screening may be included in the trial:

Males and females between 18 to 85 years of age, inclusive, at screening
Body mass index < 35 kg/m2

Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography -

Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and

Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory:

≥ 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
NYHA class II or III

Has a screening echocardiogram with the following determined by the echocardiography core laboratory:

Resting LVOT-G > 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND
LVEF ≥ 60%
Hemoglobin ≥ 10g/dL
Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks

Exclusion Criteria:

Any of the following criteria will exclude potential participants from the trial:

Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
History of intolerance or medical contraindication to beta blocker therapy
Resting SBP of > 160 mmHg
Resting heart rate of > 100 bpm

Significant valvular heart disease

Moderate-severe valvular aortic stenosis or fixed subaortic obstruction
Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment)
Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy at any time during their clinical course
Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
Documented room air oxygen saturation reading < 90% at screening
Planned septal reduction treatment that cannot be deferred during the trial period
History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
Current or recent (< 4 weeks) therapy with disopyramide
History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

170

Study ID:

NCT05767346

Recruitment Status:

Recruiting

Sponsor:

Cytokinetics

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There are 26 Locations for this study

See Locations Near You

Alaska Heart and Vascular Institute
Anchorage Alaska, 99508, United States
Mayo Clinic
Phoenix Arizona, 85054, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla California, 92037, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles California, 90048, United States
Yale New Haven Hospital
New Haven Connecticut, 06519, United States
AdventHealth
Orlando Florida, 32804, United States
Emory Clinic
Atlanta Georgia, 30322, United States
Piedmont Fayette Hospital
Fayetteville Georgia, 30214, United States
Northwestern University
Evanston Illinois, 60208, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01803, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York New York, 10032, United States
Duke Health Center Arringdon
Morrisville North Carolina, 27560, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Division of Heart Failure and Transplantation (Hospital of the University of Pennsylvania)
Philadelphia Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Ascension Saint Thomas Heart West
Nashville Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
CHI St. Luke's Health Baylor-St. Luke's Medical Center
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Intermountain Medical Center
Murray Utah, 84107, United States
Inova Schar Heart and Vascular
Falls Church Virginia, 22042, United States
Institut universitaire de cardiologie et de pneumonlogie de Quebec - Universite Laval
Québec , , Canada
Zhongshan Hospital Fudan University
Shanghai , , China
Aarhus University Hospital
Aarhus , , Denmark
Copenhagen University Hospital
Copenhagen , , Denmark
CHU La Timone
Marseille , , France
Hopital Europeen Georges Pompidou
Paris , , France
Hopital Lariboisiere - APHP
Paris , , France
Hopital Cardiologique Haut Leveque - CHU de Bordeaux
Pessac , , France
Hopital Laennec - CHU de Nantes
Saint-Herblain , , France
Charite-Universitatsmedizin Berlin - Campus Virchow Klinikum
Berlin , , Germany
Universitaetsklinikum Jena
Jena , , Germany
Semmelweis Egyetem, Városmajori Szív- és Érgyógyászati Klinika
Budapest , , Hungary
Barzilai Medical Center
Ashkelon , , Israel
Hadassah Hebrew Medical Center- Ein Kerem
Jerusalem , , Israel
The Chaim Sheba Medical Center
Ramat Gan , , Israel
Kaplan Medical Center
Reẖovot , , Israel
Ziv Medical Center
Safed , , Israel
AOU Careggi
Florence , , Italy
Erasmus Medical Center
Rotterdam , , Netherlands
Complejo Hospitalario Universitario A Coruna
A Coruña , , Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Hospital Clinico Universitario Virgen Arrixaca
El Palmar , , Spain
Hospital Universitario Puerta de Hierro
Madrid , , Spain
Hospital Universitario de Salamanca
Salamanca , , Spain
Hospital Universitario Virgen del Rocio
Sevilla , , Spain
Hospital Universitario Virgen Macarena
Sevilla , , Spain
Hospital Universitario Son Llatzer
Son Ferriol , , Spain
NHS Greater Glasgow and Clyde
Glasgow , , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool , , United Kingdom
Barts Health NHS Trust
London , , United Kingdom
Royal Brompton Hospital
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

170

Study ID:

NCT05767346

Recruitment Status:

Recruiting

Sponsor:


Cytokinetics

How clear is this clinincal trial information?

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