NCT05084235

The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure

Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Jacob Moller · Academic / Other
• Sex: All
• Age: 60 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic

Conditions

• Heart Failure
• Obesity

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
DRUG	Placebo	Placebo matches the active drug in appearance, odor and labelling

Timeline

• Start date: 2021-09-02
• Primary completion: 2025-01-16
• Completion: 2025-01-16
• First posted: 2021-10-19
• Last updated: 2025-01-29

Locations

2 sites across 1 country: Denmark