A Multicenter, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure)

About this Study

To evaluate the efficacy of AT-001 compared with placebo in preventing death or hospitalization due to cardiac events. 

Sponsor Protocol ID:AT-001-2001
IRB Number:2020V0166
Actively Enrolling
Phase 2
October 20, 2021
Eligibility Criteria
60 years old
Both Male and Female

Inclusion Criteria1. Diagnosis of Type 2 Diabetes Mellitus (T2DM) 

2. One of the following age-related criteria: 
• Age ≥ 60 years OR 
• Age ≥ 40 to
o Duration of diabetes ≥ 10 years 
o eGFR

Exclusion Criteria1. Prior diagnosis of overt/symptomatic heart failure / stage C heart failure, including any prior or current symptom or sign that led to a diagnosis of overt/symptomatic heart failure / stage C heart failure. These symptoms and signs include, but are not limited to: 
• Breathlessness 
• Orthopnea 
• Paroxysmal nocturnal dyspnea 
• Fatigue or tiredness 
• Bilateral ankle edema 
• Rales 
• Jugular venous dilatation

6. History of severe mitral, aortic, tricuspid, or pulmonary valve disease, or moderate valve disease requiring intervention 

7. History of any clinically significant arrhythmia (such as ventricular arrhythmia, permanent atrial fibrillation or history of paroxysmal atrial fibrillation requiring hospitalization)

8. History of hospitalization for hypertensive emergency

20. Pregnant or breastfeeding women 

21. Females of childbearing potential not willing to use a highly effective form of birth control

24. History of substance abuse (including alcohol) 

25. History of clinically significant drug hypersensitivity reactions 

26. Severe lower extremity complications (such as critical limb ischemia leading to skin ulcers, osteomyelitis and gangrene) and/or history of non-traumatic amputations 

Categories Click category to view its trials.
Heart Health
Participating Locations
University Heart - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Theresa Hickey
Phone Number: 601-815-8702
Email: thutson@umc.edu
Principal Investigator:Papadimitriou, Lampros, M.D., Ph.D.
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