Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

Heart Failure With Reduced Ejection Fraction Clinical Trial

— Empire HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198585
• Other study ID #: Empire HF
• Secondary ID: 2017-001341-27
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2017
• Est. completion date: January 17, 2020

Study information

• Verified date: January 2020
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 17, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• Empagliflozin 10 MG
Capsule, once a day for 90 days

Other:
• Placebo
Capsule, once a day for 90 days

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte University Hospital	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Morten Schou

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group difference in the change of plasma concentrations of NT-proBNP		90 days
Secondary	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
Secondary	Between-group difference in the change in body composition assessed by DXA scan		90 days
Secondary	Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance		90 days
Secondary	Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin		90 days
Secondary	Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test		90 days
Secondary	Between-group difference in the change of ketone supply to the heart assessed by blood ketones		90 days
Secondary	Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance		90 days
Secondary	Between-group difference in the change of uric acid		90 days
Secondary	Between-group difference in the change of urine albumin/creatinine ratio		90 days
Secondary	Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI		90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ		90 days
Secondary	Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L		90 days