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

Last updated: January 26, 2025
Sponsor: Jacob Moller
Overall Status: Completed

Phase

2

Condition

Diabetes Prevention

Chest Pain

Congestive Heart Failure

Treatment

Empagliflozin 10 MG

Placebo

Clinical Study ID

NCT05042973
S-20210028-2
  • Ages 60-84
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index >28kg/m2

  • Age 60-84 years

  • Established risk factor for developing heart failure, defined as at least one of thefollowing:

  • hypertension

  • ischemic heart disease

  • stroke/transient cerebral ischemia

  • chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion

Exclusion Criteria:

  • Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)

  • Heart failure with reduced ejection fraction (LVEF <40%)

  • Inability to perform exercise test

  • Dementia

  • Severe non-compliance

  • Substance abuse

  • Severe chronic obstructive pulmonary disease (FEV1<50% expected value)

  • Permanent atrial fibrillation

  • GFR <30 ml/min/1,73m2

  • Severe peripheral artery disease

  • Cancer treatment within one year beside prostate cancer and basal cell carcinoma

  • Severe aortic or mitral valve disease

  • Pregnancy or breastfeeding

  • Acute hospital admission within 30 days

  • Participation in other pharmacological study

Study Design

Total Participants: 165
Treatment Group(s): 2
Primary Treatment: Empagliflozin 10 MG
Phase: 2
Study Start date:
September 02, 2021
Estimated Completion Date:
January 23, 2025

Study 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.

Connect with a study center

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

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