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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

1. ≥ 15 mm in one or more myocardial segments OR
2. ≥ 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

1. Moderate-severe valvular aortic stenosis or fixed subaortic obstruction
2. 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/14/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Said Alsidawi, M.D.

Closed for enrollment

Contact information:

Aatikah Mouti M.S.

(480) 342-2479

Mouti.Aatikah@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20556629

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