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

Morten Schou2 sites in 1 country190 target enrollmentJune 29, 2017

ConditionsHeart Failure With Reduced Ejection Fraction

InterventionsEmpagliflozin 10 MG Placebo

DrugsEmpagliflozin 10 MG

Overview

Phase: Phase 2
Intervention: Empagliflozin 10 MG
Conditions: Heart Failure With Reduced Ejection Fraction
Sponsor: Morten Schou
Enrollment: 190
Locations: 2
Primary Endpoint: Between-group difference in the change of plasma concentrations of NT-proBNP
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 29, 2017

End Date

January 17, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Morten Schou

Responsible Party

Sponsor Investigator

Principal Investigator

Morten Schou

MD, PhD, Consultant Cardiologist, Associate Professor

Herlev and Gentofte Hospital

Eligibility Criteria

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
•Age \> 85 years
•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

Arms & Interventions

Empagliflozin 10 mg

Intervention: Empagliflozin 10 MG

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 90 days

Secondary Outcomes

Between-group difference in the change of uric acid(90 days)
Between-group difference in the change of urine albumin/creatinine ratio(90 days)
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)
Between-group difference in the change of ketone supply to the heart assessed by blood ketones(90 days)
Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance(90 days)
Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI(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(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(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(90 days)
Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ(90 days)
Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L(90 days)