Hypertrophic Cardiomyopathy Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 ≥ 30 and ≤ 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

Exclusion Criteria:

Significant valvular heart disease (per Investigator judgment)

Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
Moderate or severe mitral regurgitation
Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.
History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
Documented room air oxygen saturation reading < 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
Screening diastolic blood pressure ≥ 100 mmHg
Received prior treatment with aficamten
Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
Undergone septal reduction therapy < 6 months prior to screening
Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period

Paroxysmal or permanent atrial fibrillation is excluded only if:

rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening
rate control and anticoagulation have not been achieved for at least 3 months prior to screening.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT06081894

Recruitment Status:

Recruiting

Sponsor:

Cytokinetics

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There are 30 Locations for this study

See Locations Near You

Alaska Heart and Vascular Institute
Anchorage Alaska, 99508, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles California, 90048, United States
University of California San Francisco
San Francisco California, 94143, United States
Yale New Haven Hospital
New Haven Connecticut, 06519, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale Florida, 33308, United States
Northwestern University
Evanston Illinois, 60208, United States
Ascension St. Vincent
Indianapolis Indiana, 46260, United States
MedStar Union Memorial Hospital
Baltimore Maryland, 21218, 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
Michigan Medicine
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Arizona Cardiovascular Research Center
Las Vegas Nevada, 89118, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
NYU Langone Health
New York New York, 10016, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York New York, 10032, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte North Carolina, 28204, United States
The Lindner Research Center at The Christ Hospital
Cincinnati Ohio, 45219, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
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
Baylor College of Medicine
Houston Texas, 77030, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Virginia
Charlottesville Virginia, 22903, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT06081894

Recruitment Status:

Recruiting

Sponsor:


Cytokinetics

How clear is this clinincal trial information?

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