Empagliflozin in heart failure patients with reduced ejection fraction: A randomized clinical trial (Empire HF)

Jesper Jensen*, Massar Omar, Caroline Kistorp, Mikael Kjær Poulsen, Christian Tuxen, Ida Gustafsson, Lars Køber, Finn Gustafsson, Emil Fosbøl, Niels Eske Bruun, Lars Videbæk, Peter Hartmund Frederiksen, Jacob Eifer Møller, Morten Schou

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

72 Downloads (Pure)

Resumé

Background: Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong life in patients without HF. Ongoing event-driven trials are investigating whether the same effect is present in patients with well-defined HF. The mechanism behind the effect of SGLT2 inhibitors in patients with T2D and the potential effect in patients with overt HF is presently unknown. Methods: This is a randomized, double-blinded, placebo-controlled, parallel group, clinical trial including HF patients with reduced left ventricular ejection fraction (HFrEF) with an ejection fraction ≤ 40% on optimal therapy recruited from specialized HF clinics in Denmark. The primary aim is to investigate the effect of the SGLT2 inhibitor empagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary endpoints include cardiac biomarkers, function and hemodynamics, metabolic and renal parameters, daily activity level, and quality of life. Patients are assigned 1:1 to 90 days treatment with empagliflozin 10 mg daily or placebo. Patients with T2D are required to be on recommended doses of anti-glycemic therapy with a hemoglobin A1c (HbA1c) of 6.5-10.0% (48-86 mmol/mol). To show a between-group difference in the change of NT-proBNP of 30%, a total of 189 patients will be included. Discussion: The Empire HF trial will elucidate the effects and modes of action of empagliflozin in HFrEF patients with and without T2D and provide important mechanistic data which will complement ongoing event-driven trials. Trial registration: Clinicaltrialsregister.eu, EudraCT Number 2017-001341-27. Registered on 29 May 2017. ClinicalTrials.gov, NCT03198585. Registered on 26 June 2017.

OriginalsprogEngelsk
Artikelnummer374
TidsskriftTrials
Vol/bind20
Antal sider8
ISSN1745-6215
DOI
StatusUdgivet - 21. jun. 2019

Fingeraftryk

Randomized Controlled Trials
Type 2 Diabetes Mellitus
Brain Natriuretic Peptide
Placebos
Denmark
Quality of Life
Clinical Trials
Kidney

Citer dette

Jensen, Jesper ; Omar, Massar ; Kistorp, Caroline ; Poulsen, Mikael Kjær ; Tuxen, Christian ; Gustafsson, Ida ; Køber, Lars ; Gustafsson, Finn ; Fosbøl, Emil ; Bruun, Niels Eske ; Videbæk, Lars ; Frederiksen, Peter Hartmund ; Møller, Jacob Eifer ; Schou, Morten. / Empagliflozin in heart failure patients with reduced ejection fraction : A randomized clinical trial (Empire HF). I: Trials. 2019 ; Bind 20.
@article{8765a7fb684b4b329faad19e591d3adb,
title = "Empagliflozin in heart failure patients with reduced ejection fraction: A randomized clinical trial (Empire HF)",
abstract = "Background: Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong life in patients without HF. Ongoing event-driven trials are investigating whether the same effect is present in patients with well-defined HF. The mechanism behind the effect of SGLT2 inhibitors in patients with T2D and the potential effect in patients with overt HF is presently unknown. Methods: This is a randomized, double-blinded, placebo-controlled, parallel group, clinical trial including HF patients with reduced left ventricular ejection fraction (HFrEF) with an ejection fraction ≤ 40{\%} on optimal therapy recruited from specialized HF clinics in Denmark. The primary aim is to investigate the effect of the SGLT2 inhibitor empagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary endpoints include cardiac biomarkers, function and hemodynamics, metabolic and renal parameters, daily activity level, and quality of life. Patients are assigned 1:1 to 90 days treatment with empagliflozin 10 mg daily or placebo. Patients with T2D are required to be on recommended doses of anti-glycemic therapy with a hemoglobin A1c (HbA1c) of 6.5-10.0{\%} (48-86 mmol/mol). To show a between-group difference in the change of NT-proBNP of 30{\%}, a total of 189 patients will be included. Discussion: The Empire HF trial will elucidate the effects and modes of action of empagliflozin in HFrEF patients with and without T2D and provide important mechanistic data which will complement ongoing event-driven trials. Trial registration: Clinicaltrialsregister.eu, EudraCT Number 2017-001341-27. Registered on 29 May 2017. ClinicalTrials.gov, NCT03198585. Registered on 26 June 2017.",
keywords = "Cardiac function, Daily activity level, Heart failure, Mechanism, Metabolic endpoints, Mode of action, NT-proBNP, Quality of life, Renal endpoints, SGLT2 inhibitors",
author = "Jesper Jensen and Massar Omar and Caroline Kistorp and Poulsen, {Mikael Kj{\ae}r} and Christian Tuxen and Ida Gustafsson and Lars K{\o}ber and Finn Gustafsson and Emil Fosb{\o}l and Bruun, {Niels Eske} and Lars Videb{\ae}k and Frederiksen, {Peter Hartmund} and M{\o}ller, {Jacob Eifer} and Morten Schou",
year = "2019",
month = "6",
day = "21",
doi = "10.1186/s13063-019-3474-5",
language = "English",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

Jensen, J, Omar, M, Kistorp, C, Poulsen, MK, Tuxen, C, Gustafsson, I, Køber, L, Gustafsson, F, Fosbøl, E, Bruun, NE, Videbæk, L, Frederiksen, PH, Møller, JE & Schou, M 2019, 'Empagliflozin in heart failure patients with reduced ejection fraction: A randomized clinical trial (Empire HF)', Trials, bind 20, 374. https://doi.org/10.1186/s13063-019-3474-5

Empagliflozin in heart failure patients with reduced ejection fraction : A randomized clinical trial (Empire HF). / Jensen, Jesper; Omar, Massar; Kistorp, Caroline; Poulsen, Mikael Kjær; Tuxen, Christian; Gustafsson, Ida; Køber, Lars; Gustafsson, Finn; Fosbøl, Emil; Bruun, Niels Eske; Videbæk, Lars; Frederiksen, Peter Hartmund; Møller, Jacob Eifer; Schou, Morten.

I: Trials, Bind 20, 374, 21.06.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Empagliflozin in heart failure patients with reduced ejection fraction

T2 - A randomized clinical trial (Empire HF)

AU - Jensen, Jesper

AU - Omar, Massar

AU - Kistorp, Caroline

AU - Poulsen, Mikael Kjær

AU - Tuxen, Christian

AU - Gustafsson, Ida

AU - Køber, Lars

AU - Gustafsson, Finn

AU - Fosbøl, Emil

AU - Bruun, Niels Eske

AU - Videbæk, Lars

AU - Frederiksen, Peter Hartmund

AU - Møller, Jacob Eifer

AU - Schou, Morten

PY - 2019/6/21

Y1 - 2019/6/21

N2 - Background: Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong life in patients without HF. Ongoing event-driven trials are investigating whether the same effect is present in patients with well-defined HF. The mechanism behind the effect of SGLT2 inhibitors in patients with T2D and the potential effect in patients with overt HF is presently unknown. Methods: This is a randomized, double-blinded, placebo-controlled, parallel group, clinical trial including HF patients with reduced left ventricular ejection fraction (HFrEF) with an ejection fraction ≤ 40% on optimal therapy recruited from specialized HF clinics in Denmark. The primary aim is to investigate the effect of the SGLT2 inhibitor empagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary endpoints include cardiac biomarkers, function and hemodynamics, metabolic and renal parameters, daily activity level, and quality of life. Patients are assigned 1:1 to 90 days treatment with empagliflozin 10 mg daily or placebo. Patients with T2D are required to be on recommended doses of anti-glycemic therapy with a hemoglobin A1c (HbA1c) of 6.5-10.0% (48-86 mmol/mol). To show a between-group difference in the change of NT-proBNP of 30%, a total of 189 patients will be included. Discussion: The Empire HF trial will elucidate the effects and modes of action of empagliflozin in HFrEF patients with and without T2D and provide important mechanistic data which will complement ongoing event-driven trials. Trial registration: Clinicaltrialsregister.eu, EudraCT Number 2017-001341-27. Registered on 29 May 2017. ClinicalTrials.gov, NCT03198585. Registered on 26 June 2017.

AB - Background: Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong life in patients without HF. Ongoing event-driven trials are investigating whether the same effect is present in patients with well-defined HF. The mechanism behind the effect of SGLT2 inhibitors in patients with T2D and the potential effect in patients with overt HF is presently unknown. Methods: This is a randomized, double-blinded, placebo-controlled, parallel group, clinical trial including HF patients with reduced left ventricular ejection fraction (HFrEF) with an ejection fraction ≤ 40% on optimal therapy recruited from specialized HF clinics in Denmark. The primary aim is to investigate the effect of the SGLT2 inhibitor empagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary endpoints include cardiac biomarkers, function and hemodynamics, metabolic and renal parameters, daily activity level, and quality of life. Patients are assigned 1:1 to 90 days treatment with empagliflozin 10 mg daily or placebo. Patients with T2D are required to be on recommended doses of anti-glycemic therapy with a hemoglobin A1c (HbA1c) of 6.5-10.0% (48-86 mmol/mol). To show a between-group difference in the change of NT-proBNP of 30%, a total of 189 patients will be included. Discussion: The Empire HF trial will elucidate the effects and modes of action of empagliflozin in HFrEF patients with and without T2D and provide important mechanistic data which will complement ongoing event-driven trials. Trial registration: Clinicaltrialsregister.eu, EudraCT Number 2017-001341-27. Registered on 29 May 2017. ClinicalTrials.gov, NCT03198585. Registered on 26 June 2017.

KW - Cardiac function

KW - Daily activity level

KW - Heart failure

KW - Mechanism

KW - Metabolic endpoints

KW - Mode of action

KW - NT-proBNP

KW - Quality of life

KW - Renal endpoints

KW - SGLT2 inhibitors

U2 - 10.1186/s13063-019-3474-5

DO - 10.1186/s13063-019-3474-5

M3 - Journal article

C2 - 31227014

AN - SCOPUS:85068511791

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 374

ER -