NCT03198585

Brief Summary

To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

June 21, 2017

Last Update Submit

January 31, 2020

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Between-group difference in the change of plasma concentrations of NT-proBNP

    90 days

Secondary Outcomes (15)

  • Between-group difference in the change in daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units

    90 days

  • Between-group difference in the change in body composition assessed by DXA scan

    90 days

  • Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance

    90 days

  • Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin

    90 days

  • Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test

    90 days

  • +10 more secondary outcomes

Study Arms (2)

Empagliflozin 10 mg

ACTIVE COMPARATOR
Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Empagliflozin 10 MGDRUG

Capsule, once a day for 90 days

Empagliflozin 10 mg
PlaceboOTHER

Capsule, once a day for 90 days

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Optimal Heart Failure Therapy in accordance with European and National Guidelines
  • 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%

You may not qualify if:

  • CRT-D/-P implanted \< 90 days
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herlev and Gentofte University Hospital

Copenhagen, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 40502611DERIVED

  • 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.

    PMID: 35973031DERIVED

  • 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.

    PMID: 35219331DERIVED

  • 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.

    PMID: 34743533DERIVED

  • 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.

    PMID: 34509409DERIVED

  • 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.

    PMID: 34061581DERIVED

  • 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.

    PMID: 33404637DERIVED

  • 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.

    PMID: 33357505DERIVED

  • 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.

    PMID: 31227014DERIVED

MeSH Terms

Interventions

empagliflozin

Study Officials

  • Morten Schou, MD

    Herlev and Gentofte University Hospital

    PRINCIPAL INVESTIGATOR

  • Jacob E Moller, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Consultant Cardiologist, Associate Professor

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 26, 2017

Study Start

June 29, 2017

Primary Completion

December 20, 2019

Study Completion

January 17, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)