Trial Search Results

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

MyoKardia, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: mavacamten
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Key Inclusion Criteria:

   - Age 18 and greater, body weight ≥ 45kg

   - Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)

   - Diagnosed with oHCM consistent with current American College of Cardiology
   Foundation/American Heart Association and European Society of Cardiology guidelines
   and satisfy both criteria:

   - Has documented left ventricular ejection fraction (LVEF) ≥55%

   - NYHA Class II or III

   - Has documented oxygen saturation at rest ≥90% at Screening

   - Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at
   Screening per central reading

Key Exclusion Criteria:

   - Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM,
   such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy

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

   - History of resuscitated sudden cardiac arrest (at any time) or known history of
   appropriate implantable cardioverter defibrillator (ICD) discharge for
   life-threatening ventricular arrhythmia within 6 months prior to Screening

   - Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at
   Screening

   - Persistent or permanent atrial fibrillation not on anticoagulation for at least 4
   weeks prior to Screening and/or not adequately rate controlled within 6 months prior
   to Screening

   - Treatment (within 14 days prior to Screening) or planned treatment during the study
   with disopyramide or ranolazine

   - Treatment (within 14 days prior to Screening) or planned treatment during the study
   with a combination of β-blockers and calcium channel blockers

   - LVOT gradient with Valsalva maneuver <30 mmHg at Screening

   - Has been successfully treated with invasive septal reduction (surgical myectomy or
   percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or
   plans to have either of these treatments during the study

   - ICD placement within 2 months prior to Screening or planned ICD placement during the
   study

   - Has a history or evidence of any other clinically significant disorder, condition, or
   disease that, in the opinion of the investigator, would pose a risk to participant
   safety or interfere with the study evaluation, procedures, or completion

   - Prior treatment with cardiotoxic agents such as doxorubicin or similar

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting