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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042973
• Other study ID #: S-20210028-2
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2, 2021
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Odense University Hospital
• Contact: Camilla Fuchs Andersen, MD
• Phone: +45 28144737
• Email: camilla.fuchs.andersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Obesity

Intervention

Drug:
• Empagliflozin 10 MG
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
• Placebo
Placebo matches the active drug in appearance, odor and labelling.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (6)

Lead Sponsor	Collaborator
Jacob Moller	Danish Heart Foundation, Herlev and Gentofte Hospital, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome: fat tissue gene expression	Between-group difference in fat tissue gene expression assessed by Western Blot	180 days
Other	Exploratory outcome: oxidative stress and inflammation.	Between-group difference in biomarkers of oxidative stress and inflammation.	180 days
Primary	Epicardial adipose tissue (EAT)	Between-group difference in the change of EAT volume assessed by cardiac magnetic resonance imaging (MRI)	180 days
Primary	Estimated extracellular volume (eECV)	Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)	180 days
Secondary	Body composition	Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan	180 days
Secondary	Plasma volume	Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin	180 days
Secondary	Glucose tolerance	Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test	180 days
Secondary	Kidney function (measured)	Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance	180 days
Secondary	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
Secondary	Uric acid	Between-group difference in the change of uric acid	180 days
Secondary	Urine albumin/creatinine ratio	Between-group difference in the change of urine albumin/creatinine ratio	180 days
Secondary	Right ventricle	Between-group difference in the change of right ventricular systolic and diastolic dimensions assessed by cardiac MRI	180 days
Secondary	Pericardial fat mass	Between-group difference in the change of pericardial fat mass assessed by cardiac MRI	180 days
Secondary	Ketone bodies	Between-group difference in the change of ketone supply to the heart assessed by blood ketones	180 days
Secondary	Erythropoietin	Between-group difference in the change of erythropoietin	180 days