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NCT03485222 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
84
Enrollment target

NCT03485222 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 84 participants.

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The verdict

NCT03485222, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
84 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebos
  • DRUG Empagliflozin

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2018-05-21
Est. Completion 2020-02-13
Phase Phase 4

What the Registry Record Tells You About NCT03485222

The ClinicalTrials.gov registry entry for NCT03485222 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.

NCT03485222 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03485222 about?

NCT03485222 is a clinical study titled "Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).". 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 eff...

What is the current status of trial NCT03485222?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2018-05-21. Estimated completion is 2020-02-13.

What interventions are being tested in trial NCT03485222?

The interventions under investigation include: Placebos (DRUG), Empagliflozin (DRUG).

Who is sponsoring clinical trial NCT03485222?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.