CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM

Overview

Información sobre este estudio

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

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Key Inclusion Criteria:

- Males and females between 18 and 85 years of age, inclusive, at screening.

- Body mass index <35 kg/m2.

- Diagnosed with HCM per the following criteria:

- Has LV hypertrophy and 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 of:

- ≥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

- Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as
determined by the echocardiography core laboratory.

- LVEF ≥60% at screening as determined by the echocardiography core laboratory.

- NYHA Functional Class II or III at screening.

- Hemoglobin ≥10g/dL at screening.

- Respiratory exchange ratio (RER) ≥1.05 and pVO2 <80% predicted on the screening CPET
per the core laboratory.

- Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on
stable doses for >6 weeks prior to randomization and anticipate remaining on the same
medication regimen during the trial. Patients treated with disopyramide must also be
concomitantly treated with a beta blocker and/or calcium channel blocker.

Key Exclusion Criteria:

- Known or suspected infiltrative, genetic or storage disorder causing cardiac
hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).

- Significant valvular heart disease (per investigator judgment).

- Moderate-severe valvular aortic stenosis.

- Moderate-severe mitral regurgitation not due to systolic anterior motion of the
mitral valve.

- 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).

- Has been treated with septal reduction therapy (surgical myectomy or percutaneous
alcohol septal ablation) or has plans for either treatment during the trial period.

- Documented paroxysmal atrial fibrillation during the screening period.

- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg,
direct-current cardioversion, atrial fibrillation ablation procedure, or
antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply
if atrial fibrillation has been treated with anticoagulation and adequately
rate-controlled for >6 months.)

- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
months prior to screening.

- Has received prior treatment with CK-3773274 or mavacamten.

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

Eligibility last updated 5/31/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Jeffrey Geske, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Melissa Lyle, M.D.

Cerrado para la inscripción

More information

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