Empagliflozin to elderly and obese patients with cardiovascular disease (Empire Prevent): A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005317-40-DK

Enrollment

204

Registered

2021-04-07

Start date

2021-05-27

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese patients (BMI >28 kg/m2), aged 60-84 years, with documented cardiovascular disease but no history of diabetes mellitus or heart failure with reduced ejection fraction.

Interventions

Trade Name: Jardiance Pharmaceutical Form: Coated tablet INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Age 60-84 years (2) Bodymass index >28 kg/m2 (3) Documented cardiovascular disease by any one of following: (3a) Hypertension (3b) Documented ischemic heart disease (3c) Stroke or transitory cerebral ischemia (3d) Chronic kidney disease with GFR 30-45 ml/min/1,72m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104

Exclusion criteria

Exclusion criteria: (1) Diabetes mellitus (type 1 or 2) (2) Heart failure with ejection fraction <40% (3) Inability to perform exercise test (4) Dementia (5) Non-compliance (6) Substance abuse (7) GFR <30 ml/min/1,72m2 (8) Severe chronic obstructive pulmonary disease (FEV1< 50% expected value) (9) Permanent atrial fibrillation (10) Severe peripheral artery disease (11) Cancer treatment within one year beside prostate cancer and basal cell carcinoma (12) Severe aortic or mitral valve disease (13) Acute hospital admission within 30 days (14) Participation in other pharmacological study (15) Pregnancy (16) Breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Empire Prevent: Cardiac (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can improve peak oxygen consumption (VO2) in elderly and obese patients with cardiovascular disease. (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce left ventricular (LV) mass index in elderly and obese patients with cardiovascular disease Empire Prevent: Metabolic (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce estimated extracellular volume (eECV) in elderly and obese patients with cardiovascular disease. (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce epicardial adipose tissue (EAT) in elderly and obese patients with cardiovascular disease;Secondary Objective: Empire Prevent: Cardiac (1) To investigate whether the improvement in peak VO2 is associated with improvement in daily activity level measured by an accelerometer and self-reported quality of life. (2) To evaluate whether reduction in LV mass is associated with reduction in cardiac fibrosis and left atrial maximal volume. Empire Prevent: Metabolic (1) To evaluate whether the decrease in eECV is associated with a decrease in estimated plasma volume (ePV) and further, if these changes are accompanied by a reduction in s-urate and a stabilization of glomerular filtration rate. (2) To evaluate whether reduction in EAT is associated with a reduction in pericardial adipose tissue ;Primary end point(s): (1) Change from baseline in peak oxygen consumption (VO2) in elderly (2) Change from baseline in left ventricular (LV) mass index (3) Change from baseline in estimated extracellular volume (eECV) (4) Change from baseline in epicardial adipose tissue (EAT);Timepoint(s) of evaluation of this end point: Day 0 and day 180	—

Measure

Time frame

Main Objective: Empire Prevent: Cardiac (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can improve peak oxygen consumption (VO2) in elderly and obese patients with cardiovascular disease. (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce left ventricular (LV) mass index in elderly and obese patients with cardiovascular disease Empire Prevent: Metabolic (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce estimated extracellular volume (eECV) in elderly and obese patients with cardiovascular disease. (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce epicardial adipose tissue (EAT) in elderly and obese patients with cardiovascular disease;Secondary Objective: Empire Prevent: Cardiac (1) To investigate whether the improvement in peak VO2 is associated with improvement in daily activity level measured by an accelerometer and self-reported quality of life. (2) To evaluate whether reduction in LV mass is associated with reduction in cardiac fibrosis and left atrial maximal volume. Empire Prevent: Metabolic (1) To evaluate whether the decrease in eECV is associated with a decrease in estimated plasma volume (ePV) and further, if these changes are accompanied by a reduction in s-urate and a stabilization of glomerular filtration rate. (2) To evaluate whether reduction in EAT is associated with a reduction in pericardial adipose tissue ;Primary end point(s): (1) Change from baseline in peak oxygen consumption (VO2) in elderly (2) Change from baseline in left ventricular (LV) mass index (3) Change from baseline in estimated extracellular volume (eECV) (4) Change from baseline in epicardial adipose tissue (EAT);Timepoint(s) of evaluation of this end point: Day 0 and day 180

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline in: (1) Daily activity level measured by an accelerometer (2) Self-reported quality of life (3) Cardiac fibrosis (4) Left atrial maximal and minimal volume (5) Ambulatory blood pressure (6) Arterial vascular stiffness (7) Plasma concentrations of ketone bodies (8) Pericardial and paracardial adipose tissue (9) Visceral adipose tissue (10) Glycemic control (11) Estimated plasma volume (12) Secretion of erythropoietin, hepcidin and erythroferrone (13) Changes in ferritin, transferrin saturation and reticulocyte count (14) Serum urate (14) Glomerular filtration rate (15) Right ventricular dimensions (diastolic and systolic) ;Timepoint(s) of evaluation of this end point: Day 0 and day 180	—

Measure

Time frame

Secondary end point(s): Change from baseline in: (1) Daily activity level measured by an accelerometer (2) Self-reported quality of life (3) Cardiac fibrosis (4) Left atrial maximal and minimal volume (5) Ambulatory blood pressure (6) Arterial vascular stiffness (7) Plasma concentrations of ketone bodies (8) Pericardial and paracardial adipose tissue (9) Visceral adipose tissue (10) Glycemic control (11) Estimated plasma volume (12) Secretion of erythropoietin, hepcidin and erythroferrone (13) Changes in ferritin, transferrin saturation and reticulocyte count (14) Serum urate (14) Glomerular filtration rate (15) Right ventricular dimensions (diastolic and systolic) ;Timepoint(s) of evaluation of this end point: Day 0 and day 180

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Countries

Denmark

Contacts

Public ContactJulie Hempel Larsen

Odense Universitetshospital

julie.hempel.larsen@rsyd.dk4528935466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026