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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001341-27-DK

Enrollment

190

Registered

2017-04-10

Start date

2017-05-29

Completion date

Unknown

Last updated

2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with reduced ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10078289 Term: Heart failure with reduced ejection fraction System Organ Class: 100000004849

Interventions

Trade Name: Jardiance Pharmaceutical Form: Capsule INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria: (1) CRT-D/-P implanted 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

Design outcomes

Primary

Measure	Time frame
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 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) ;Secondary Objective: Exploratory study To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on daily activity level measured by patient-worn accelerometer	—

Measure

Time frame

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 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) ;Secondary Objective: Exploratory study To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on daily activity level measured by patient-worn accelerometer

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Secondary

Measure	Time frame
Secondary end point(s): Between-group difference in the change from baseline in (1) daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units (2) Body composition and estimated plasma volume (ePV) assessed by DXA-scan, hematocrit (Hct) and hemoglobin (Hgb) (3) Glucose metabolism assessed by OGTT (4) Ketone supply to the heart assessed by blood ketones (5) Renal function and estimated extracellular volume (eECV) assessed by Cr-51 EDTA, uric acid and U-albumin/-creatinine ratio (6) Cardiac biomarkers assessed by MR-proADM and hs-cTNI (7) Cardiac systolic and diastolic function including LV-GLS and LVEF assessed by transthoracic echocardiography at rest and during stress (8) Cardiac hemodynamics at rest and during sub-maximal exercise assessed by right heart catheterization including PCWP/CI index and LV contractile reserve (9) Health-related quality of life assessed by the questionnaires KCCQ and EQ-5D-5L ;Timepoint(s) of evaluation of this end point: 90 days after baseline	—

Measure

Time frame

Secondary end point(s): Between-group difference in the change from baseline in (1) daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units (2) Body composition and estimated plasma volume (ePV) assessed by DXA-scan, hematocrit (Hct) and hemoglobin (Hgb) (3) Glucose metabolism assessed by OGTT (4) Ketone supply to the heart assessed by blood ketones (5) Renal function and estimated extracellular volume (eECV) assessed by Cr-51 EDTA, uric acid and U-albumin/-creatinine ratio (6) Cardiac biomarkers assessed by MR-proADM and hs-cTNI (7) Cardiac systolic and diastolic function including LV-GLS and LVEF assessed by transthoracic echocardiography at rest and during stress (8) Cardiac hemodynamics at rest and during sub-maximal exercise assessed by right heart catheterization including PCWP/CI index and LV contractile reserve (9) Health-related quality of life assessed by the questionnaires KCCQ and EQ-5D-5L ;Timepoint(s) of evaluation of this end point: 90 days after baseline

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Countries

Denmark

Contacts

Public ContactJesper Jensen

Department of Cardiology, Herlev-Gentofte University Hospital

jesper.jensen.06@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026