ACTIVE_NOT_RECRUITING

A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).

Official Title

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy

Quick Facts

Study Start:2024-04-11

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06347159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \< 40 kg/m2 is permitted for participants \< 50 years). * Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines. * LVOT peak gradient ≥ 50 mmHg measured at rest or during the Valsalva maneuver as determined by echocardiography at Screening (Part A, B and D oHCM only). * LVOT peak gradient \< 30 mmHg measured at rest and \< 50 mmHg measured during the Valsalva maneuver as determined by echocardiography at Screening (Part C and D nHCM only). * 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 at Screening. * NT-proBNP ≥ 300 pg/mL (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).	* Invasive septal reduction therapy \< 180 days prior to or during Screening. * Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease \< 180 days prior to Screening. * 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 or regurgitation, moderate or greater mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve) * History of LV systolic dysfunction (LVEF \< 0.45) or stress cardiomyopathy at any time. * Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy. * A history of unexplained syncope \<180 days prior to or during Screening. * A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest \< 180 days 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 to Screening. * History of permanent AF or atrial flutter. Documented AF or atrial flutter requiring rhythm restoring treatment \< 180 days prior to Screening Visit (participants with documented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 days prior to Screening require adequate anticoagulation.) * Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety at Screening (QTcF \< 530 ms is permitted for participants with documented bundle branch blockage (BBB) and/or cardiac pacing). * Receiving a CMI (e.g., Camzyos® \[mavacamten\] or aficamten) \< 90 days prior to Screening.

Inclusion Criteria

Exclusion 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 \< 40 kg/m2 is permitted for participants \< 50 years).
* Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines.
* LVOT peak gradient ≥ 50 mmHg measured at rest or during the Valsalva maneuver as determined by echocardiography at Screening (Part A, B and D oHCM only).
* LVOT peak gradient \< 30 mmHg measured at rest and \< 50 mmHg measured during the Valsalva maneuver as determined by echocardiography at Screening (Part C and D nHCM only).
* 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 at Screening.
* NT-proBNP ≥ 300 pg/mL (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).

* Invasive septal reduction therapy \< 180 days prior to or during Screening.
* Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease \< 180 days prior to Screening.
* 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 or regurgitation, moderate or greater mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve)
* History of LV systolic dysfunction (LVEF \< 0.45) or stress cardiomyopathy at any time.
* Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
* A history of unexplained syncope \<180 days prior to or during Screening.
* A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest \< 180 days 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 to Screening.
* History of permanent AF or atrial flutter. Documented AF or atrial flutter requiring rhythm restoring treatment \< 180 days prior to Screening Visit (participants with documented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 days prior to Screening require adequate anticoagulation.)
* Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety at Screening (QTcF \< 530 ms is permitted for participants with documented bundle branch blockage (BBB) and/or cardiac pacing).
* Receiving a CMI (e.g., Camzyos® \[mavacamten\] or aficamten) \< 90 days prior to Screening.

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Edgewise Therapeutics, Inc.

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Stanford University Hospital / Stanford Health Care

Stanford, California, 94305

United States

Emory Clinic

Atlanta, Georgia, 30322

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Brigham and Womens Hospital

Boston, Massachusetts, 02115

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Michigan Medicine - Michigan Clinical Research Unit

Ann Arbor, Michigan, 48109

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Morristown Medical Center (Atlantic Health System)

Morristown, New Jersey, 07960

United States

North Shore University Hospital

Manhasset, New York, 11030

United States

NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)

New York, New York, 10016

United States

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204

United States

Duke Health Center Arringdon

Morrisville, North Carolina, 27560

United States

The Lindner Research Center at Christ Hospital

Cincinnati, Ohio, 45219

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Philadelphia, Pennsylvania, 19104

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

University of Virginia Heart and Vascular Center Fontaine

Charlottesville, Virginia, 22903

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Edgewise Therapeutics, Inc.

Medical Director, STUDY_DIRECTOR, Edgewise Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-04-11

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Hypertrophic Cardiomyopathy