Phase
Condition
Congestive Heart Failure
Circulation Disorders
Heart Defect
Treatment
EDG-7500
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male or nonpregnant female, age ≥18 years to <85 years.
Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening.
Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent withcurrent American College of Cardiology Foundation/American Heart AssociationGuidelines
LVOT peak gradient ≥50 mmHg measured at rest or during the Valsalva maneuver asdetermined by echocardiography at Screening (Part A, B and D oHCM only).
LVOT peak gradient < 30 mmHg measured at rest and < 50 mmHg measured during theValsalva maneuver as determined by echocardiography at Screening (Part C and D nHCMonly).
Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
New York Heart Association (NYHA) Classification II-III at Screening.
Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 85 atScreening.
NT-proBNP ≥ 300 pg/mL (Part C and D nHCM only).
Exclusion
Key Exclusion Criteria:
Invasive septal reduction any time prior to Screening.
Documented current or history of obstructive coronary artery disease at any time ormyocardial infarction any time prior to Screening.
Significant valvular hear disease (moderate-severe aortic stenosis or regurgitation,moderate-severe mitral stenosis or regurgitation not due to systolic anterior motionof the mitral valve)
History of LV systolic dysfunction (LVEF < 0.45) or stress cardiomyopathy at anytime.
Known or suspected infiltrative or storage disorder causing cardiac hypertrophy thatmay mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LVhypertrophy.
A history of unexplained syncope or sustained ventricular tachyarrhythmia orsupraventricular tachycardia <180 days prior to Screening.
A history of sudden cardiac arrest at any time or known appropriate implantablecardioverter defibrillator (ICD) discharge <180 days prior to Screening
History of permanent AF or atrial flutter. Any episode of documented AF or atrialflutter < 180 days prior to Screening Visit (participants with documented AF oratrial flutter ≥ 180 days prior to Screening require adequate anticoagulation andrate control.)
Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormalityconsidered by the Investigator or Medical Monitor to pose a risk to participantsafety.
Current or prior use of a cardiac myosin inhibitor <90 days prior to Screening.
Study Design
Connect with a study center
University of California, San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Stanford University Hospital / Stanford Health Care
Stanford, California 94305
United StatesActive - Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida 33612
United StatesActive - Recruiting
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesActive - Recruiting
Morristown Medical Center (Atlantic Health System)
Morristown, New Jersey 07960
United StatesActive - Recruiting
North Shore University Hospital
Manhasset, New York 11030
United StatesActive - Recruiting
NYU Langone Health Medical Center - HCM Program Office
New York, New York 10016
United StatesActive - Recruiting
Sanger Heart and Vascular Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon 97239
United StatesActive - Recruiting
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
University of Virginia Heart and Vascular Center Fontaine
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesActive - Recruiting
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