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

Morten Schou

Status and phase: Completed; Phase 2

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: Placebo; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03198585

Empire HF

2017-001341-27 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 190 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

Empagliflozin 10 mg

Active Comparator group

Treatment:

Drug: Empagliflozin 10 MG

Placebo

Placebo Comparator group

Treatment:

Other: Placebo