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| Name | Class |
|---|---|
| Danish Heart Foundation | OTHER |
| Herlev and Gentofte Hospital | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
| Hillerod Hospital, Denmark |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug (Empagliflozin) | Active Comparator | Empagliflozin 10 mg, 1 capsule per day |
|
| Inactive drug (placebo) | Placebo Comparator | Placebo, 1 capsule per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular epicardial adipose tissue (EAT) mass | Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI) | 180 days |
| Estimated extracellular volume (eECV) | Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid) | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total pericardial adipose tissue volume | Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI | 180 days |
| Total epicardial adipose tissue (EAT) volume |
| Measure | Description | Time Frame |
|---|---|---|
| Erythropoietin | Between-group difference in the change of erythropoietin | 180 days |
| Exploratory outcome: fat tissue gene expression | Between-group difference in fat tissue gene expression assessed by Western Blot |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten Schou, MD, PhD | Herlev-Gentofte Hospital | Principal Investigator |
| Jacob Eifer Møller, MD, PhD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2730 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286641 | Derived | Andersen CF, Larsen JH, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Knop FK, Forman JL, Davidovski FS, Kober L, Sabaratnam R, Hojlund K, Schou M, Moller JE, Jensen J. The effect of empagliflozin on inflammation in patients with overweight or obesity and risk of heart failure: a substudy from the Empire Prevent Metabolic trial. Cardiovasc Diabetol. 2026 Jun 12. doi: 10.1186/s12933-026-03216-x. Online ahead of print. | |
| 38365073 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Jan 24, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006333 | Heart Failure |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| OTHER |
| Rigshospitalet, Denmark | OTHER |
Parallel Assignment
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| Placebo | Drug | Placebo matches the active drug in appearance, odor and labelling. |
|
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
| 180 days |
| Plasma volume | Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin | 180 days |
| Right ventricular end-diastolic volume index, RVEDVI | Between-group difference in the change of RVEDVI assessed by cardiac MRI | 180 days |
| 180 days |
| Exploratory outcome: oxidative stress and inflammation. | Between-group difference in biomarkers of oxidative stress and inflammation. | 180 days |
| Ketone bodies | Between-group difference in the change of ketone supply to the heart assessed by blood ketones | 180 days |
| Urine albumin/creatinine ratio | Between-group difference in the change of urine albumin/creatinine ratio | 180 days |
| Uric acid | Between-group difference in the change of uric acid | 180 days |
| Kidney function (estimated) | Between-group difference in the change of estimated glomerular filtration rate (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) estimation | 180 days |
| Kidney function (measured) | Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance | 180 days |
| Glucose tolerance | Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test | 180 days |
| Body composition | Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan | 180 days |
| Odense |
| 5000 |
| Denmark |
| Derived |
| Andersen CF, Larsen JH, Jensen J, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Gustafsson F, Knop FK, Forman JL, Davidovski FS, Jensen LT, Hojlund K, Kober L, Antonsen L, Poulsen MK, Schou M, Moller JE. Empagliflozin to elderly and obese patients with increased risk of developing heart failure: Study protocol for the Empire Prevent trial program. Am Heart J. 2024 May;271:84-96. doi: 10.1016/j.ahj.2024.02.005. Epub 2024 Feb 15. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |