Empagliflozin in heart failure patients with reduced ejection fraction:A randomized clinical trial (Empire HF)

Phase 1

• Conditions: Heart failure with reduced ejection fraction; MedDRA version: 20.0Level: LLTClassification code 10078289Term: Heart failure with reduced ejection fractionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001341-27-DK
• Lead Sponsor: Morten Schou

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-10
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

(1) Optimal Heart Failure Therapy in accordance with European and National Guidelines
(3) LVEF = 0.40
(4) eGFR > 30 ml/min/1.73 m2
(5) BMI < 45 kg/m2
(6) NYHA class I-III
(7) Age > 18 years
(8) If T2D – optimal treatment in accordance with European and National Guidelines
(9) If T2D – stable doses of antiglycemic treatment for 30 days
(10) If T2D – HbA1C 6.5-10 %

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 133

Exclusion Criteria

(1) CRT-D/-P implanted < 90 days
(2) Uncorrected severe valvular disease
(3) Non-compliance
(4) Use of metalozone
(5) NYHA IV
(6) Age > 85 years
(7) Dementia
(8) Admission for HF < 30 days
(9) Admission for hypoglycemia < 12 month
(10) Known sustained VT
(11) Symptomatic hypotension and systolic BP < 95 mmHg
(12) Unable to perform an exercise test
(13) Immobilization
(14) Pregnancy
(15) Participation in other medical trials
(16) Previous intolerance of Empagliflozin or excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Between-group difference in the change from baseline in plasma concentrations of NT-proBNP;Timepoint(s) of evaluation of this end point: 90 days after baseline ;Main Objective: Main study<br>To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on changes in plasma concentrations of NT-proBNP in stable, symptomatic HF patients with reduced left ventricular ejection fraction (LVEF)<br>;Secondary Objective: Exploratory study<br>To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on daily activity level measured by patient-worn accelerometer