The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial
1 other identifier
interventional
191
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started Sep 2021
Typical duration for phase_2 heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2021
CompletedFirst Submitted
Initial submission to the registry
September 3, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2025
CompletedJanuary 29, 2025
January 1, 2025
3.4 years
September 3, 2021
January 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Left ventricular mass index
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
180 days
Maximal oxygen consumption
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
180 days
Secondary Outcomes (3)
Left ventricular volume
180 days
Left ventricular function
180 days
Daily activity level
180 days
Other Outcomes (9)
Quality-of-life scores
180 days
Blood pressure
180 days
Wall stress
180 days
- +6 more other outcomes
Study Arms (2)
Empaglifloxin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jacob Mollerlead
- Danish Heart Foundationcollaborator
- Herlev and Gentofte Hospitalcollaborator
- University Hospital Bispebjerg and Frederiksbergcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
Herlev Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Related Publications (3)
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.
PMID: 7053293BACKGROUNDCarter-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.
PMID: 31168387BACKGROUNDAndersen 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.
PMID: 38365073DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Eifer Møller, MD, PhD,
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Morten Schou, MD, PhD, DmSc
Herlev-Gentofte Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
September 3, 2021
First Posted
October 19, 2021
Study Start
September 2, 2021
Primary Completion
January 16, 2025
Study Completion
January 16, 2025
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share