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Completed

NCT Number: NCT05042973

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Glucose Intolerance Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herlev Hospital, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index >28kg/m2
  • Age 60-84 years
  • Established risk factor for developing heart failure, defined as at least one of the following:
  • hypertension
  • ischemic heart disease
  • stroke/transient cerebral ischemia
  • chronic kidney disease (eGFR 30-45ml/min/1.73m2)

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

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Placebo

Drug

Placebo matches the active drug in appearance, odor and labelling.

Primary outcomes

  1. Ventricular epicardial adipose tissue (EAT) mass

    Time frame: 180 days

    Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)

  2. Estimated extracellular volume (eECV)

    Time frame: 180 days

    Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)

Secondary outcomes

  1. Total pericardial adipose tissue volume

    Time frame: 180 days

    Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI

  2. Total epicardial adipose tissue (EAT) volume

    Time frame: 180 days

    Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)

  3. Plasma volume

    Time frame: 180 days

    Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin

  4. Right ventricular end-diastolic volume index, RVEDVI

    Time frame: 180 days

    Between-group difference in the change of RVEDVI assessed by cardiac MRI

Other outcomes

  1. Erythropoietin

    Time frame: 180 days

    Between-group difference in the change of erythropoietin

  2. Exploratory outcome: fat tissue gene expression

    Time frame: 180 days

    Between-group difference in fat tissue gene expression assessed by Western Blot

  3. Exploratory outcome: oxidative stress and inflammation.

    Time frame: 180 days

    Between-group difference in biomarkers of oxidative stress and inflammation.

  4. Ketone bodies

    Time frame: 180 days

    Between-group difference in the change of ketone supply to the heart assessed by blood ketones

  5. Urine albumin/creatinine ratio

    Time frame: 180 days

    Between-group difference in the change of urine albumin/creatinine ratio

  6. Uric acid

    Time frame: 180 days

    Between-group difference in the change of uric acid

  7. Kidney function (estimated)

    Time frame: 180 days

    Between-group difference in the change of estimated glomerular filtration rate (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) estimation

  8. Kidney function (measured)

    Time frame: 180 days

    Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance

  9. Glucose tolerance

    Time frame: 180 days

    Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test

  10. Body composition

    Time frame: 180 days

    Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan

Sponsors and collaborators

Lead sponsor

Jacob Moller

Other

Collaborators

  • Danish Heart Foundation
  • Herlev and Gentofte Hospital
  • Hillerod Hospital, Denmark
  • Rigshospitalet, Denmark
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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