Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

Phase 2

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Placebo; Drug: Empagliflozin 10 MG

• Registration Number: NCT03198585
• Lead Sponsor: Morten Schou

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2017-06-29
• Primary Completion: 2019-12-20
• Status Verified: 2020-01
• Study Completion: 2020-01-17
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Empagliflozin 10 mg	Empagliflozin 10 MG	-

Primary Outcome Measures

Name	Time	Method
Between-group difference in the change of plasma concentrations of NT-proBNP	90 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Herlev and Gentofte University Hospital; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark