RECRUITING

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

Conditions

Quick Navigation

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:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status: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. * Body mass index (BMI) ≥18 to \<38 kg/m2; weight ≥50 kg at Screening. * Diagnosed with hypertrophic cardiomyopathy 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 (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 as assessed by the Investigator at Screening (Part C and D nHCM only). * Maximal exercise peak LVOT gradient \< 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation \< 12 months prior to dosing or 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.	* 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 * Documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan \<3 years prior to Screening). * 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 * A history of diabetes with a hemoglobin A1C ≥ 7.5% at the Screening Visit (Part C and D nHCM only)

Inclusion Criteria

Exclusion 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 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 (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 as assessed by the Investigator at Screening (Part C and D nHCM only).
* Maximal exercise peak LVOT gradient \< 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation \< 12 months prior to dosing or 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.

* 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
* Documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan \<3 years prior to Screening).
* 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
* A history of diabetes with a hemoglobin A1C ≥ 7.5% at the Screening Visit (Part C and D nHCM only)

Contacts and Locations

Study Contact

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002

cardiacstudies@edgewisetx.com

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

James A. Haley Veterans' Hospital

Tampa, Florida, 33612

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

North Shore University Hospital

Manhasset, New York, 11030

United States

NYU Langone Health Medical Center - HCM Program Office

New York, New York, 10016

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

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 Date2026-03

Study Record Updates

Study Start Date2024-04-11

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Hypertrophic Cardiomyopathy