Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).

• Status: Completed
• Trial end date: 2020-02-13
• Target enrollment: 0
• Participant gender: All

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 of the postulated non-glucose dependent effects, the researchers will investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in heart failure patients with reduced ejection fraction without diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Boehringer Ingelheim; Eli Lilly and Company
• Treatments: Empagliflozin; Hypoglycemic Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.