Hypertrophic Cardiomyopathy Clinical Trial
A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM)
Summary
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy.
Eligibility Criteria
Key Inclusion Criteria:
Male or nonpregnant female, age ≥18 years.
Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening.
Diagnosed with HCM at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines
LVOT peak gradient ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva as determined by echocardiography at Screening.
Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
New York Heart Association (NYHA) Classification I-III at Screening.
Key Exclusion Criteria:
Invasive septal reduction <180 days prior to Screening.
Documented current or history of obstructive coronary artery disease at any time or myocardial infarction <180 days prior to Screening.
Known Stage B or higher aortic valve stenosis or regurgitation
A history of syncope or sustained ventricular tachyarrhythmia <180 days prior to Screening.
A history of sudden cardiac arrest at any time or known appropriate implantable cardioverter 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 or ablation for AF <90 days of Screening.
Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator to pose a risk to participant safety.
Current or prior use of any cardiac myosin inhibitors
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States More Info
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