NCT05042973

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (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 lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed. The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.

Detailed description

The Empire Prevent: Metabolic is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Cardiac. The Empire Prevent: Metabolic is designed to enroll at least 120 patients.

Conditions

• Obesity
• Heart Failure

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: 2025-01-23
• First posted: 2021-09-13
• Last updated: 2025-01-29

Locations

2 sites across 1 country: Denmark