Phase
Condition
Cardiomyopathy
Cardiac Disease
Heart Disease
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 (BMI ≥ 18 to < 40kg/m2 is permitted for participants < 50 years).
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 (NT-proBNP ≥ 225 pg/mL is permitted for African Americanparticipants) (Part C and D nHCM only).
Exclusion
Key Exclusion Criteria:
Invasive septal reduction therapy < 180 days prior to or during Screening.
Documented history of active or untreated obstructive coronary artery disease duringScreening or treated for obstructive coronary artery disease < 180 days prior toScreening.
Documented history of myocardial infarction with residual wall motion abnormalities < 180 days prior to or during Screening.
Significant valvular heart disease (moderate or greater aortic stenosis orregurgitation, moderate or greater mitral stenosis or regurgitation not due tosystolic anterior motion of 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 <180 days prior to or during Screening.
A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest < 180days prior or during Screening.
A history of known appropriate implantable cardioverter defibrillator (ICD)discharge <180 days prior to or during Screening or ICD implanted < 14 days prior toScreening.
History of permanent AF or atrial flutter. Documented AF or atrial flutter requiringrhythm restoring treatment < 180 days prior to Screening Visit (participants withdocumented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 daysprior to Screening require adequate anticoagulation.)
Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormalityconsidered by the Investigator or Medical Monitor to pose a risk to participantsafety at Screening (QTcF < 530 ms is permitted for participants with documentedbundle branch blockage (BBB) and/or cardiac pacing).
Receiving a CMI (e.g., Camzyos® [mavacamten] or aficamten) < 90 days prior toScreening.
Study Design
Connect with a study center
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
Stanford University Hospital / Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
University of California, San Francisco
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Stanford University Hospital / Stanford Health Care
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
James A. Haley Veterans' Hospital
Tampa, Florida 33612
United StatesSite Not Available
James A. Haley Veterans' Hospital
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Emory Clinic
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Lahey Hospital and Medical Center
Burlington 4931737, Massachusetts 6254926 01805
United StatesSite Not Available
Michigan Medicine - Michigan Clinical Research Unit
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Morristown Medical Center (Atlantic Health System)
Morristown, New Jersey 07960
United StatesSite Not Available
Morristown Medical Center (Atlantic Health System)
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
NYU Langone Health Medical Center - HCM Program Office
New York, New York 10016
United StatesSite Not Available
North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
United StatesSite Not Available
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Duke Health Center Arringdon
Morrisville 4480285, North Carolina 4482348 27560
United StatesSite Not Available
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
The Lindner Research Center at Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 33612
United StatesSite Not Available
Oregon Health & Science University (OHSU)
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health & Science University (OHSU)
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
University of Virginia Heart and Vascular Center Fontaine
Charlottesville, Virginia 22903
United StatesSite Not Available
University of Virginia Heart and Vascular Center Fontaine
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Virginia Mason Medical Center
Seattle 5809844, Washington 5815135 98101
United StatesSite Not Available

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