Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction (Empire HF)

January 31, 2020 updated by: Morten Schou

Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2730
        • Herlev and Gentofte University Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  • Previous intolerance of Empagliflozin or excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
Capsule, once a day for 90 days
ACTIVE_COMPARATOR: Empagliflozin 10 mg
Drug: Empagliflozin 10 MG
Capsule, once a day for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Between-group difference in the change of plasma concentrations of NT-proBNP
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 90 days
90 days
Between-group difference in the change in body composition assessed by DXA scan
Time Frame: 90 days
90 days
Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance
Time Frame: 90 days
90 days
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Time Frame: 90 days
90 days
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
Time Frame: 90 days
90 days
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
Time Frame: 90 days
90 days
Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance
Time Frame: 90 days
90 days
Between-group difference in the change of uric acid
Time Frame: 90 days
90 days
Between-group difference in the change of urine albumin/creatinine ratio
Time Frame: 90 days
90 days
Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI
Time Frame: 90 days
90 days
Between-group difference in the change of cardiac systolic and diastolic function including left ventricular global longitudinal strain and left ventricular ejection fraction assessed by transthoracic echocardiography at rest and during stress
Time Frame: 90 days
90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including pulmonary capillary wedge pressure to cardiac index ratio
Time Frame: 90 days
90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including left ventricular contractile reserve
Time Frame: 90 days
90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ
Time Frame: 90 days
90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Schou

Investigators

  • Principal Investigator: Morten Schou, MD, Herlev and Gentofte University Hospital
  • Principal Investigator: Jacob E Moller, MD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2017

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

January 17, 2020

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (ACTUAL)

June 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Empire HF
  • 2017-001341-27 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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