A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) (NCT06347159) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
United States79 participantsStarted 2024-04-11
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion 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).
Key Exclusion Criteria:
* 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 Scre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)