The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
NCT ID: NCT05084235
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2021-09-02
2025-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Empaglifloxin
Empagliflozin 10 MG
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Placebo
Placebo
Placebo matches the active drug in appearance, odor and labelling
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
84 Years
ALL
No
Sponsors
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Danish Heart Foundation
OTHER
Herlev and Gentofte Hospital
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Hillerod Hospital, Denmark
OTHER
Rigshospitalet, Denmark
OTHER
Jacob Moller
OTHER
Responsible Party
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Jacob Moller
Professor, MD, PhD
Principal Investigators
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Jacob Eifer Møller, MD, PhD,
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Morten Schou, MD, PhD, DmSc
Role: PRINCIPAL_INVESTIGATOR
Herlev-Gentofte Hospital
Locations
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Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Carter-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.
Andersen 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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S-20210028-1
Identifier Type: -
Identifier Source: org_study_id
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