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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03485222

Run by

Icahn School of Medicine at Mount Sinai

People needed

84

Starts

2018-05-21

Expected to finish

2020-02-13

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mount Sinai Heart - Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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