At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 84 enrolled
Drug / intervention
Empagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EMPA-TROPISM Trial: Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity?
In Brief
A Phase 4 clinical trial evaluating Empagliflozin and Placebos for Cardiovascular Diseases. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases
CountriesUnited States
CollaboratorsBoehringer Ingelheim, Eli Lilly and Company
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartMay 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedApr 2, 2018
Enrollment StartMay 21, 2018
Primary CompletionFeb 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.3 years ago
Interventions
Empagliflozindrug
6 months
Placebosdrug
placebo equivalent for 6 months