Status:
COMPLETED
Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Boehringer Ingelheim
Eli Lilly and Company
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Purpose: The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were, at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the existence ...
Detailed Description
Heart failure (HF) is a frequent co-morbid condition associated with poor prognosis in diabetes, particularly among older patients. HF accounts for more than 1 Million hospitalizations annually in USA...
Eligibility Criteria
Inclusion
- Patients should meet the following inclusion criteria:
- Ambulatory patients age 18-85 years
- Diagnosis of Heart failure (NYHA II to III)
- LVEF\<50% on echocardiography or CMRI in the previous 6 months
- Have stable symptoms and therapy for HF within the last 3 months.
Exclusion
- Pregnant or lactating women.
- Any history of diabetes by medical history or by any of the established criteria by the American Diabetes Association. It also includes patients with history of diabetes in remission.
- ACS or cardiac surgery within the last 3 months.
- Cancer or any other life-threatening condition.
- Pancreatitis.
- Glomerular Filtration Rate \< 45 ml/Kg/min.
- Use of continuous parental inotropic agents.
- Systolic BP \< 90 mm Hg.
- Psychiatric disease incompatible with being in study.
- Any contraindication to MRI procedures.
- Any other medical or physical condition considered to be inappropriate by a study physician.
Key Trial Info
Start Date :
May 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03485222
Start Date
May 21 2018
End Date
February 13 2020
Last Update
March 25 2021
Active Locations (1)
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1
Mount Sinai Heart - Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029