Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (NCT04083339) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
United States, Australia, Canada675 participantsStarted 2019-09-20
Plain-language summary
This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.
Who can participate
Age range
40 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.
Inclusion Criteria:
* Type 2 Diabetes Mellitus
* Diabetic cardiomyopathy
* Peak VO2 \< 75% of predicted normal value based on age and gender
Exclusion Criteria:
* Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
* Prior echocardiogrphic measurement of ejection fraction (EF) \< 40%
* Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
* Severe or moderate cardiac valve disease requiring intervention
* Clinically significant arrhythmia
* Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
* Blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at screening
* HbA1c \>8.5% at screening
* Severe disease that would impact the performance of a cardio-pulmonary exercise test
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
Peak VO2 during cardio-pulmonary exercise test (CPET);