ObesityPhase 2NCT05042973
The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
A Phase 2 study testing Empagliflozin 10 MG in people with Obesity and Heart Failure, run by Jacob Moller at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 60 to 84 years
- Conditions the study is for
- Obesity, Heart Failure
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 2 sitesDenmark
- Study dates
- 2 Sep 2021to 23 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity, Heart Failure
- Being tested
- Empagliflozin 10 MG, Placebo
- Keywords
- Renal function, Glucose intolerance, Lipid metabolism
- Medical subject headings
- Obesity, Heart Failure, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
PlaceboDrug
Placebo matches the active drug in appearance, odor and labelling.
| Study group | Role | What they receive |
|---|---|---|
| Active drug (Empagliflozin) | Active comparator | Empagliflozin 10 mg, 1 capsule per day Receives: Drug: Empagliflozin 10 MG |
| Inactive drug (placebo) | Placebo comparator | Placebo, 1 capsule per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular epicardial adipose tissue (EAT) mass
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Measured: 180 days
Estimated extracellular volume (eECV)
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
Measured: 180 days
Secondary outcomes (4)
Total pericardial adipose tissue volume
Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI
Measured: 180 days
Total epicardial adipose tissue (EAT) volume
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Measured: 180 days
Plasma volume
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Measured: 180 days
Right ventricular end-diastolic volume index, RVEDVI
Between-group difference in the change of RVEDVI assessed by cardiac MRI
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start2 Sep 2021
- Primary completion16 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob Moller
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Jacob Moller, Odense University Hospital
- Investigators
- Morten Schou, MD, PhD, Principal investigator, Herlev-Gentofte HospitalJacob Eifer Møller, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042973
- Sponsor's protocol ID
- S-20210028-2
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42286641Andersen 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.
PubMed 38365073
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05042973
- Acronym / sponsor ID
- S-20210028-2
- Conditions
- Obesity, Heart Failure
- Keywords
- Renal function, Glucose intolerance, Lipid metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Jacob MollerUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Active drug (Empagliflozin) | Active comparator | Drug: Empagliflozin 10 MGEmpagliflozin 10 mg, 1 capsule per day |
| Inactive drug (placebo) | Placebo comparator | Drug: PlaceboPlacebo, 1 capsule per day |
Who may qualify
- Ages
- 60 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGPatients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days | Drug | Active drug (Empagliflozin) |
| PlaceboPlacebo matches the active drug in appearance, odor and labelling. | Drug | Inactive drug (placebo) |
Primary outcome
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)
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)
4 secondary outcomes
Total pericardial adipose tissue volume
Time frame: 180 days
Total epicardial adipose tissue (EAT) volume
Time frame: 180 days
Plasma volume
Time frame: 180 days
Right ventricular end-diastolic volume index, RVEDVI
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 42286641Andersen 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.
- Derived from this study: PubMed 38365073Andersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Schou, MD, PhD principal investigator
Herlev-Gentofte Hospital
Jacob Eifer Møller, MD, PhD principal investigator
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG in people with Obesity and Heart Failure, run by Jacob Moller at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular epicardial adipose tissue (EAT) mass (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.