CIRRUS-HCM (Hypertrophic Cardiomyopathy)

CIRRUS-HCM (Hypertrophic Cardiomyopathy)

Es posible que algunos contenidos no estén disponibles en español.

Purpose of this Study

We are doing this study to find out if an experimental drug called EDG-7500 (the study drug) is a safe and effective option for patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM). The study drug is designed to help the heart's ability to relax by making contractions more controlled, and we want to know how successful the drug is in achieving its intended outcome.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have a body mass index (BMI) that is less than 38 kg/m2
  • Have a left ventricular ejection fraction of at least 60%
  • Have New York Heart Association (NYHA) Classification I-III HCM at the start of the study
  • Have not had any changes to their dosing within 30 days of joining the study if they use a beta blocker
For more information, contact the study team at joshua.stablein@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will participate in 1 of 4 different parts to the study:
  • Part A (lasts about 2-6 weeks): In this part, you will be screened for eligibility, have a single clinic visit to get the study drug, and have follow-up visits with the study team. You will get only one dose of the study drug.
  • Part B & Part C (each lasts about 2.5 months): In this part, you will be screened for eligibility, take the study drug every day for 28 days at home, and have follow-up visits with the study team.
  • Part D (lasts about 12.5 months): In this part, you will be screened for eligibility, take the study drug every day for 48 weeks at home, and have follow-up visits with the study team.
Procedures during your study visits will include physical exams, genetic testing, blood draws, heart function tests (ECG, echocardiograms), and symptom assessments. Some tests, like stress tests, are optional. If you take part in Part A, you will get a random assignment to be placed into 1 of several groups that will get different doses of the study drug. Neither you nor the study team can choose your group assignment, but we will let you know what it is.

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

Andrew
Wang

Protocol Number

PRO00117443

NCT ID

NCT06347159

Phase

II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov