Back to resultsThe Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
Primary Purpose
Obesity, Heart Failure
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Renal function, Glucose intolerance, Lipid metabolism
Eligibility Criteria
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
Sites / Locations
- Herlev HospitalRecruiting
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active drug (Empagliflozin)
Inactive drug (placebo)
Arm Description
Empagliflozin 10 mg, 1 capsule per day
Placebo, 1 capsule per day
Outcomes
Primary Outcome Measures
Epicardial adipose tissue (EAT)
Between-group difference in the change of EAT volume assessed by cardiac magnetic resonance imaging (MRI)
Estimated extracellular volume (eECV)
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
Secondary Outcome Measures
Body composition
Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan
Plasma volume
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Glucose tolerance
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
Kidney function (measured)
Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance
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
Uric acid
Between-group difference in the change of uric acid
Urine albumin/creatinine ratio
Between-group difference in the change of urine albumin/creatinine ratio
Right ventricle
Between-group difference in the change of right ventricular systolic and diastolic dimensions assessed by cardiac MRI
Pericardial fat mass
Between-group difference in the change of pericardial fat mass assessed by cardiac MRI
Ketone bodies
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
Erythropoietin
Between-group difference in the change of erythropoietin
Full Information
NCT ID
NCT05042973
First Posted
September 3, 2021
Last Updated
April 5, 2023
Sponsor
Jacob Moller
Collaborators
Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05042973
Brief Title
The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
Official Title
Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob Moller
Collaborators
Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Heart Failure
Keywords
Renal function, Glucose intolerance, Lipid metabolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active drug (Empagliflozin)
Arm Type
Active Comparator
Arm Description
Empagliflozin 10 mg, 1 capsule per day
Arm Title
Inactive drug (placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo, 1 capsule per day
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matches the active drug in appearance, odor and labelling.
Primary Outcome Measure Information:
Title
Epicardial adipose tissue (EAT)
Description
Between-group difference in the change of EAT volume assessed by cardiac magnetic resonance imaging (MRI)
Time Frame
180 days
Title
Estimated extracellular volume (eECV)
Description
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Body composition
Description
Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan
Time Frame
180 days
Title
Plasma volume
Description
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Time Frame
180 days
Title
Glucose tolerance
Description
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
Time Frame
180 days
Title
Kidney function (measured)
Description
Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance
Time Frame
180 days
Title
Kidney function (estimated)
Description
Between-group difference in the change of estimated glomerular filtration rate (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) estimation
Time Frame
180 days
Title
Uric acid
Description
Between-group difference in the change of uric acid
Time Frame
180 days
Title
Urine albumin/creatinine ratio
Description
Between-group difference in the change of urine albumin/creatinine ratio
Time Frame
180 days
Title
Right ventricle
Description
Between-group difference in the change of right ventricular systolic and diastolic dimensions assessed by cardiac MRI
Time Frame
180 days
Title
Pericardial fat mass
Description
Between-group difference in the change of pericardial fat mass assessed by cardiac MRI
Time Frame
180 days
Title
Ketone bodies
Description
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
Time Frame
180 days
Title
Erythropoietin
Description
Between-group difference in the change of erythropoietin
Time Frame
180 days
Other Pre-specified Outcome Measures:
Title
Exploratory outcome: fat tissue gene expression
Description
Between-group difference in fat tissue gene expression assessed by Western Blot
Time Frame
180 days
Title
Exploratory outcome: oxidative stress and inflammation.
Description
Between-group difference in biomarkers of oxidative stress and inflammation.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Fuchs Andersen, MD
Phone
+45 28144737
Email
camilla.fuchs.andersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Hempel Larsen, MD
Phone
+45 28935466
Email
julie.hempel.larsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Schou, MD, PhD
Organizational Affiliation
Herlev-Gentofte Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Eifer Møller, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla F Andersen, MD
Phone
+45 28144737
Email
camilla.fuchs.andersen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Professor Morten Schou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Camilla F Andersen, MD
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie H Larsen, MD
Phone
+45 28935466
Email
Julie.Hempel.Larsen@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Professor Jacob E Møller, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julie H Larsen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
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