Heart FailurePhase 2NCT05084235
The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
A Phase 2 study testing Empagliflozin 10 MG in people with Heart Failure and Obesity, run by Jacob Moller at 2 sites in Denmark.
Trial summary
The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. Read more about this study
- Who is it for?
- Ages 60 to 84 years
- Conditions the study is for
- Heart Failure, Obesity
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 2 sitesDenmark
- Study dates
- 2 Sep 2021to 16 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: Cardiac): A Randomized Controlled Trial
The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.
Read the detailed description
The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic
- Conditions
- Heart Failure, Obesity
- Being tested
- Empagliflozin 10 MG, Placebo
- Medical subject headings
- Heart Failure, Obesity
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 |
|---|---|---|
| Empaglifloxin | Active comparator | Not described Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass index
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
Measured: 180 days
Maximal oxygen consumption
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
Measured: 180 days
Secondary outcomes (3)
Left ventricular volume
Between-group difference in the change of left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI) assessed by cardiac magnetic resonance image
Measured: 180 days
Left ventricular function
Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image
Measured: 180 days
Daily activity level
Between-group difference in the change of daily activity level assessed by accelerometer
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 posted19 Oct 2021
- Study start2 Sep 2021
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 191 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
- Jacob Eifer Møller, MD, PhD,, Principal investigator, Odense University HospitalMorten Schou, MD, PhD, DmSc, Principal investigator, Herlev-Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084235
- Sponsor's protocol ID
- S-20210028-1
- 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
Reichek N, Wilson J, St John Sutton M, Plappert TA, Goldberg S, Hirshfeld JW. Noninvasive determination of left ventricular end-systolic stress: validation of the method and initial application. Circulation. 1982 Jan;65(1):99-108. doi: 10.1161/01.cir.65.1.99. No abstract available.
PubMed 7053293Carter-Storch R, Moller JE, Christensen NL, Rasmussen LM, Pecini R, Sondergard E, Videbaek LM, Dahl JS. End-systolic wall stress in aortic stenosis: comparing symptomatic and asymptomatic patients. Open Heart. 2019 Apr 9;6(1):e001021. doi: 10.1136/openhrt-2019-001021. eCollection 2019.
PubMed 31168387Andersen 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: Cardiac): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05084235
- Acronym / sponsor ID
- S-20210028-1
- Conditions
- Heart Failure, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 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
- 16 Jan 2025 (actual)
- First posted
- 19 Oct 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 cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.
Detailed description
The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empaglifloxin | Active comparator | Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Drug: Placebo |
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 | Empaglifloxin |
| PlaceboPlacebo matches the active drug in appearance, odor and labelling | Drug | Placebo |
Primary outcome
Left ventricular mass index
Time frame: 180 days
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
Maximal oxygen consumption
Time frame: 180 days
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
3 secondary outcomes
Left ventricular volume
Time frame: 180 days
Left ventricular function
Time frame: 180 days
Daily activity level
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.
- Background: PubMed 7053293Reichek N, Wilson J, St John Sutton M, Plappert TA, Goldberg S, Hirshfeld JW. Noninvasive determination of left ventricular end-systolic stress: validation of the method and initial application. Circulation. 1982 Jan;65(1):99-108. doi: 10.1161/01.cir.65.1.99. No abstract available.
- Background: PubMed 31168387Carter-Storch R, Moller JE, Christensen NL, Rasmussen LM, Pecini R, Sondergard E, Videbaek LM, Dahl JS. End-systolic wall stress in aortic stenosis: comparing symptomatic and asymptomatic patients. Open Heart. 2019 Apr 9;6(1):e001021. doi: 10.1136/openhrt-2019-001021. eCollection 2019.
- 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.
Jacob Eifer Møller, MD, PhD, principal investigator
Odense University Hospital
Morten Schou, MD, PhD, DmSc principal investigator
Herlev-Gentofte 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 Heart Failure and Obesity, 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?
Left ventricular mass index (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 NCT05084235, which also lists 3 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.