Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction
NCT ID: NCT03198585
Last Updated: 2020-02-05
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
190 participants
INTERVENTIONAL
2017-06-29
2020-01-17
Brief Summary
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The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin 10 mg
Empagliflozin 10 MG
Capsule, once a day for 90 days
Placebo
Placebo
Capsule, once a day for 90 days
Interventions
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Empagliflozin 10 MG
Capsule, once a day for 90 days
Placebo
Capsule, once a day for 90 days
Eligibility Criteria
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Inclusion Criteria
* LVEF ≤ 0.40
* eGFR \> 30 ml/min/1.73 m2
* BMI \< 45 kg/m2
* NYHA class I-III
* Age \> 18 years
* If T2D - optimal treatment in accordance with European and National Guidelines
* If T2D - stable doses of antiglycemic treatment for 30 days
* If T2D - HbA1C 6.5-10%
Exclusion Criteria
* Uncorrected severe valvular disease
* Non-compliance
* Use of metalozone
* NYHA IV
* Age \> 85 years
* Dementia
* Admission for HF \< 30 days
* Admission for hypoglycemia \< 12 month
* Known sustained VT
* Symptomatic hypotension and systolic BP \< 95 mmHg
* Unable to perform an exercise test
* Immobilization
* Pregnancy
* Participation in other medical trials
* Previous intolerance of Empagliflozin or excipients
18 Years
85 Years
ALL
No
Sponsors
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Morten Schou
OTHER
Responsible Party
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Morten Schou
MD, PhD, Consultant Cardiologist, Associate Professor
Principal Investigators
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Morten Schou, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev and Gentofte University Hospital
Jacob E Moller, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Herlev and Gentofte University Hospital
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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Omar M, Jensen J, Frederiksen PH, Ali M, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Borlaug BA, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Effects of Empagliflozin on Right Ventricular Function in Heart Failure with Reduced Ejection Fraction. medRxiv [Preprint]. 2025 Jun 2:2025.05.30.25328686. doi: 10.1101/2025.05.30.25328686.
Jensen J, Omar M, Kistorp C, Tuxen C, Poulsen MK, Faber J, Kober L, Gustafsson F, Moller JE, Schou M. Effect of Empagliflozin on Multiple Biomarkers in Heart Failure: Insights From the Empire Heart Failure Trial. Circ Heart Fail. 2022 Aug;15(8):e009333. doi: 10.1161/CIRCHEARTFAILURE.121.009333. Epub 2022 Apr 21. No abstract available.
Omar M, Jensen J, Kistorp C, Hojlund K, Videbaek L, Tuxen C, Larsen JH, Andersen CF, Gustafsson F, Kober L, Schou M, Moller JE. The effect of empagliflozin on growth differentiation factor 15 in patients with heart failure: a randomized controlled trial (Empire HF Biomarker). Cardiovasc Diabetol. 2022 Feb 27;21(1):34. doi: 10.1186/s12933-022-01463-2.
Omar M, Jensen J, Burkhoff D, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Gustafsson F, Kober L, Borlaug BA, Schou M, Moller JE. Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis From the Empire HF Randomized Clinical Trial. Circ Heart Fail. 2022 Mar;15(3):e009156. doi: 10.1161/CIRCHEARTFAILURE.121.009156. Epub 2021 Nov 8.
Omar M, Jensen J, Frederiksen PH, Videbaek L, Poulsen MK, Brond JC, Gustafsson F, Borlaug BA, Schou M, Moller JE. Hemodynamic Determinants of Activity Measured by Accelerometer in Patients With Stable Heart Failure. JACC Heart Fail. 2021 Nov;9(11):824-835. doi: 10.1016/j.jchf.2021.05.013. Epub 2021 Sep 8.
Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Forman JL, Moller JE, Schou M. Metabolic Effects of Empagliflozin in Heart Failure: A Randomized, Double-Blind, and Placebo-Controlled Trial (Empire HF Metabolic). Circulation. 2021 Jun;143(22):2208-2210. doi: 10.1161/CIRCULATIONAHA.120.053463. Epub 2021 Jun 1. No abstract available.
Omar M, Jensen J, Ali M, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Associations of Empagliflozin With Left Ventricular Volumes, Mass, and Function in Patients With Heart Failure and Reduced Ejection Fraction: A Substudy of the Empire HF Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):836-840. doi: 10.1001/jamacardio.2020.6827.
Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Malik ME, Fosbol EL, Bruun NE, Forman JL, Jensen LT, Moller JE, Schou M. Effects of empagliflozin on estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate in patients with heart failure (Empire HF Renal): a prespecified substudy of a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2021 Feb;9(2):106-116. doi: 10.1016/S2213-8587(20)30382-X. Epub 2020 Dec 22.
Jensen J, Omar M, Kistorp C, Poulsen MK, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Fosbol E, Bruun NE, Videbaek L, Frederiksen PH, Moller JE, Schou M. Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF). Trials. 2019 Jun 21;20(1):374. doi: 10.1186/s13063-019-3474-5.
Other Identifiers
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2017-001341-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Empire HF
Identifier Type: -
Identifier Source: org_study_id
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