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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: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction of the left ventricle (LV). Change from baseline to study end at 6 months.
Interventions
- DRUG Placebos
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2020-02-13 |
| Phase | Phase 4 |
What the finished NCT03485222 record still lists
NCT03485222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03485222 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03485222's enrollment target sits among peer trials
84 929th of 2000 higher than 1,064 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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