Phase
Condition
Cardiomyopathy
Congestive Heart Failure
Circulation Disorders
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.
Body mass index (BMI) ≥18 to <38 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 ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva 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 as assessed by the Investigatorat Screening (Part C and D nHCM only).
Maximal exercise peak LVOT gradient < 50 mmHg as determined by echocardiography asassessed by the Investigator (historical documentation < 12 months prior to dosingor confirmed at Screening) (Part C and D nHCM only).
Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
New York Heart Association (NYHA) Classification I-III at Screening.
Exclusion
Key Exclusion Criteria:
Invasive septal reduction <180 days prior to Screening.
Documented current or history of obstructive coronary artery disease at any time ormyocardial infarction <180 days prior to Screening.
Known Stage B or higher aortic valve stenosis or regurgitation
Documented current or history of cardiac amyloidosis (age ≥ 60 years requiresexclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screeningor historical scan <3 years prior to Screening).
A history of syncope or sustained ventricular tachyarrhythmia <180 days prior toScreening.
A history of sudden cardiac arrest at any time or known appropriate implantablecardioverter defibrillator (ICD) discharge <180 days prior to Screening
Atrial fibrillation (AF) at Screening; a current diagnosis of permanent AF;paroxysmal or persistent AF <90 days of Screening, or electrical cardioversion orablation for AF <90 days of Screening.
Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormalityconsidered by the Investigator to pose a risk to participant safety.
Current or prior use of any cardiac myosin inhibitors ≥ 7.5% at the Screening Visit (Part Cand D nHCM only)
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
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
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
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesActive - Recruiting
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