CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 191 enrolled
Drug / intervention
Empagliflozin 10 MG +1 moredrug
Likely dose
Empagliflozin 10 MGfrom 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/NCT05084235
NCT05084235Phase 2Completed
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Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial

Jacob Moller·interventional·Posted Oct 19, 2021·Updated Jan 29, 2025

In Brief

A Phase 2 clinical trial evaluating Empagliflozin 10 MG and Placebo for Heart Failure and Obesity. Completed, enrolled 191 participants across 2 sites.

Detailed Summary

The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Obesity
CountriesDenmark
CollaboratorsDanish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 19, 2021
Enrollment StartSep 2, 2021
Primary CompletionJan 16, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 4.7 years ago

Interventions

Empagliflozin 10 MGdrug

Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days

Placebodrug

Placebo matches the active drug in appearance, odor and labelling