CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Empagliflozin 10mg +1 moredrug
Likely dose
Empagliflozin 10mgfrom 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.

Search/NCT03128528
NCT03128528Phase 2Completed
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Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure

University of Erlangen-Nürnberg Medical School·interventional·Posted Apr 25, 2017·Updated Sep 28, 2020

In Brief

A Phase 2 clinical trial evaluating Empagliflozin 10mg and Placebo Oral Tablet for Chronic Heart Failure. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartJul 1, 2017
Primary CompletionJan 31, 2020
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.2 years ago

Interventions

Empagliflozin 10mgdrug

Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor.

Placebo Oral Tabletdrug

Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor.